Trial Outcomes & Findings for Bioequivalence Study of Fixed Dose Versus Single Entities of Dolutegravir and Lamivudine (NCT NCT03078556)
NCT ID: NCT03078556
Last Updated: 2019-02-21
Results Overview
Blood samples were collected at indicated time points to study the pharmacokinetic (PK) profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
154 participants
Primary outcome timeframe
Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Results posted on
2019-02-21
Participant Flow
The study was conducted in 2 parts (Part 1 and Part 2) at a single center in the United States from 27-March-2017 to 18-August-2017 and 154 participants (78 in Part 1 and 76 in Part 2) were randomized. First 16 participants completing the first 2 dosing periods, returned for a 3rd treatment period and received single dose of FDC with high fat meal
A total of 283 (Part 1: 150, Part 2: 133) participants were screened for this study; 125 (Part 1: 72, Part2: 53) participants were screen failures (SF) and 4 participants were reserved but not used. The reasons for SF: inclusion/exclusion criteria not met (105), withdrew consent (18), physician decision (2).
Participant milestones
| Measure |
Part 1:DTG+EPIVIR/DTG+3TC Monolayer/DTG+3TC Monolayer-fed
Participants were randomized to receive dolutegravir (DTG) 50 milligram (mg) tablet plus a single lamivudine (3TC) tablet in Period 1 followed by DTG 50 mg/3TC 300 mg fixed dose combination (FDC) monolayer formulation in Period 2. The first 16 participants who completed treatment periods 1 and 2, received a single dose of the FDC monolayer tablet formulation administered with a high fat meal in Period 3. There was a washout of 7 days between treatment periods.
|
Part 1:DTG+3TC Monolayer/DTG+EPIVIR/DTG+3TC Monolayer-fed
Participants were randomized to receive DTG 50 mg/3TC 300 mg FDC monolayer formulation in Period 1 followed by DTG 50 mg tablet plus a single 3TC tablet in Period 2. The first 16 participants who completed treatment periods 1 and 2, received a single dose of the FDC monolayer tablet formulation administered with a high fat meal in Period 3. There was a washout of 7 days between treatment periods.
|
Part 2:DTG+EPIVIR/DTG+3TC Bilayer/DTG+3TC Bilayer-fed
Participants were randomized to receive DTG 50 mg tablet plus a single 3TC tablet in Period 1 followed by DTG 50 mg/3TC 300 mg FDC bilayer formulation in Period 2. The first 16 participants who completed treatment periods 1 and 2, received a single dose of the FDC bilayer tablet formulation administered with a high fat meal in Period 3. There was a washout of 7 days between treatment periods.
|
Part 2:DTG+3TC Bilayer/DTG+EPIVIR /DTG+3TC Bilayer-fed
Participants were randomized to receive DTG 50 mg/3TC 300 mg FDC bilayer formulation in Period 1 followed by DTG 50 mg tablet plus a single 3TC tablet in Period 2. The first 16 participants who completed treatment periods 1 and 2, received a single dose of the FDC bilayer tablet formulation administered with a high fat meal in Period 3. There was a washout of 7 days between treatment periods.
|
|---|---|---|---|---|
|
Treatment Period 1 (4 Days)
STARTED
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39
|
39
|
38
|
38
|
|
Treatment Period 1 (4 Days)
COMPLETED
|
39
|
38
|
38
|
38
|
|
Treatment Period 1 (4 Days)
NOT COMPLETED
|
0
|
1
|
0
|
0
|
|
Washout Period 1 (7 Days)
STARTED
|
39
|
38
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38
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38
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|
Washout Period 1 (7 Days)
COMPLETED
|
37
|
36
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37
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37
|
|
Washout Period 1 (7 Days)
NOT COMPLETED
|
2
|
2
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1
|
1
|
|
Treatment Period 2 (4 Days)
STARTED
|
37
|
36
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37
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37
|
|
Treatment Period 2 (4 Days)
COMPLETED
|
37
|
36
|
37
|
37
|
|
Treatment Period 2 (4 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout Period 2 (7 Days)
STARTED
|
9
|
7
|
7
|
9
|
|
Washout Period 2 (7 Days)
COMPLETED
|
9
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7
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7
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9
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|
Washout Period 2 (7 Days)
NOT COMPLETED
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0
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0
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0
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0
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Treatment Period 3 (4 Days)
STARTED
|
9
|
7
|
7
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9
|
|
Treatment Period 3 (4 Days)
COMPLETED
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9
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7
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7
|
9
|
|
Treatment Period 3 (4 Days)
NOT COMPLETED
|
0
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0
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0
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0
|
Reasons for withdrawal
| Measure |
Part 1:DTG+EPIVIR/DTG+3TC Monolayer/DTG+3TC Monolayer-fed
Participants were randomized to receive dolutegravir (DTG) 50 milligram (mg) tablet plus a single lamivudine (3TC) tablet in Period 1 followed by DTG 50 mg/3TC 300 mg fixed dose combination (FDC) monolayer formulation in Period 2. The first 16 participants who completed treatment periods 1 and 2, received a single dose of the FDC monolayer tablet formulation administered with a high fat meal in Period 3. There was a washout of 7 days between treatment periods.
|
Part 1:DTG+3TC Monolayer/DTG+EPIVIR/DTG+3TC Monolayer-fed
Participants were randomized to receive DTG 50 mg/3TC 300 mg FDC monolayer formulation in Period 1 followed by DTG 50 mg tablet plus a single 3TC tablet in Period 2. The first 16 participants who completed treatment periods 1 and 2, received a single dose of the FDC monolayer tablet formulation administered with a high fat meal in Period 3. There was a washout of 7 days between treatment periods.
|
Part 2:DTG+EPIVIR/DTG+3TC Bilayer/DTG+3TC Bilayer-fed
Participants were randomized to receive DTG 50 mg tablet plus a single 3TC tablet in Period 1 followed by DTG 50 mg/3TC 300 mg FDC bilayer formulation in Period 2. The first 16 participants who completed treatment periods 1 and 2, received a single dose of the FDC bilayer tablet formulation administered with a high fat meal in Period 3. There was a washout of 7 days between treatment periods.
|
Part 2:DTG+3TC Bilayer/DTG+EPIVIR /DTG+3TC Bilayer-fed
Participants were randomized to receive DTG 50 mg/3TC 300 mg FDC bilayer formulation in Period 1 followed by DTG 50 mg tablet plus a single 3TC tablet in Period 2. The first 16 participants who completed treatment periods 1 and 2, received a single dose of the FDC bilayer tablet formulation administered with a high fat meal in Period 3. There was a washout of 7 days between treatment periods.
|
|---|---|---|---|---|
|
Treatment Period 1 (4 Days)
Adverse Event
|
0
|
1
|
0
|
0
|
|
Washout Period 1 (7 Days)
Lost to Follow-up
|
2
|
0
|
1
|
0
|
|
Washout Period 1 (7 Days)
Adverse Event
|
0
|
1
|
0
|
1
|
|
Washout Period 1 (7 Days)
Physician Decision
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Bioequivalence Study of Fixed Dose Versus Single Entities of Dolutegravir and Lamivudine
Baseline characteristics by cohort
| Measure |
Part 1
n=78 Participants
Participants were randomized into treatment sequence A/B (treatment A in Period 1 followed by B in Period 2) or B/A (treatment B in Period 1 followed by A in Period 2), where A=dolutegravir (DTG) 50 milligram (mg) tablet plus a single lamivudine (3TC) tablet and treatment B= DTG 50 mg/3TC 300 mg fixed dose combination (FDC) monolayer formulation. The first 16 participants who completed treatment periods 1 and 2, received a single dose of the FDC monolayer tablet formulation administered with a high fat meal in Period 3. There was a washout period of at least 7 days between each treatment period. In treatment periods 1 and 2, single dose of the treatments were administered in the fasted state.
|
Part 2
n=76 Participants
Participants were randomized into treatment sequence A/C (treatment A in Period 1 followed by C in Period 2) or C/A (treatment C in Period 1 followed by A in Period 2), where A=DTG 50 mg tablet plus a single 3TC tablet and treatment C= DTG 50 mg/3TC 300 mg FDC bilayer formulation. The first 16 participants who completed treatment periods 1 and 2, received a single dose of the FDC bilayer tablet formulation administered with a high fat meal in Period 3. There was a washout period of at least 7 days between each treatment period.
|
Total
n=154 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.4 Years
STANDARD_DEVIATION 9.37 • n=5 Participants
|
31.6 Years
STANDARD_DEVIATION 11.18 • n=7 Participants
|
30.5 Years
STANDARD_DEVIATION 10.33 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian- Central/South Asian Heritage
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian- East Asian Heritage
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian- South East Asian Heritage
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
20 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White-White/Caucasian/European Heritage
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dosePopulation: PK Parameter Bioequivalence (BE) Summary Population comprised of all participants who have evaluable PK parameters for both analytes and for both Period 1 and Period 2.
Blood samples were collected at indicated time points to study the pharmacokinetic (PK) profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Outcome measures
| Measure |
A: DTG 50 mg + EPIVIR 300 mg
n=73 Participants
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
n=73 Participants
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
|
Part 2- A: DTG 50 mg + EPIVIR 300 mg
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
|
|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity [AUC (0-Inf)] of Plasma DTG and 3TC in the Fasted State: Part 1
DTG
|
43.1456 Hour*micrograms per milliliter
Geometric Coefficient of Variation 39.29
|
54.8793 Hour*micrograms per milliliter
Geometric Coefficient of Variation 31.60
|
—
|
—
|
—
|
—
|
|
Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity [AUC (0-Inf)] of Plasma DTG and 3TC in the Fasted State: Part 1
3TC
|
12.3337 Hour*micrograms per milliliter
Geometric Coefficient of Variation 19.88
|
12.7603 Hour*micrograms per milliliter
Geometric Coefficient of Variation 19.77
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dosePopulation: PK Parameter BE Summary Population. Only those participants with data available at the specified data points were analyzed, represented by n= X,X in the category titles.
Blood samples were collected at given time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted conditions in Periods 1 and 2 of Part 2.
Outcome measures
| Measure |
A: DTG 50 mg + EPIVIR 300 mg
n=74 Participants
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
n=74 Participants
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
|
Part 2- A: DTG 50 mg + EPIVIR 300 mg
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
|
|---|---|---|---|---|---|---|
|
AUC (0-Inf) of Plasma DTG and 3TC in the Fasted State: Part 2
DTG, n= 74,74
|
47.2391 Hours*micrograms per milliliter
Geometric Coefficient of Variation 40.29
|
54.5594 Hours*micrograms per milliliter
Geometric Coefficient of Variation 32.12
|
—
|
—
|
—
|
—
|
|
AUC (0-Inf) of Plasma DTG and 3TC in the Fasted State: Part 2
3TC, n= 73,74
|
12.7713 Hours*micrograms per milliliter
Geometric Coefficient of Variation 18.63
|
13.5624 Hours*micrograms per milliliter
Geometric Coefficient of Variation 17.94
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dosePopulation: PK Parameter BE Summary Population.
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Outcome measures
| Measure |
A: DTG 50 mg + EPIVIR 300 mg
n=73 Participants
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
n=73 Participants
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
|
Part 2- A: DTG 50 mg + EPIVIR 300 mg
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
|
|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve From Time 0 to the Last Quantifiable Time Point (AUC[0-t]) of Plasma DTG and 3TC in the Fasted State: Part 1
DTG
|
41.4207 Hours*micrograms per milliliter
Geometric Coefficient of Variation 39.36
|
52.8754 Hours*micrograms per milliliter
Geometric Coefficient of Variation 31.16
|
—
|
—
|
—
|
—
|
|
Area Under the Concentration-time Curve From Time 0 to the Last Quantifiable Time Point (AUC[0-t]) of Plasma DTG and 3TC in the Fasted State: Part 1
3TC
|
12.1571 Hours*micrograms per milliliter
Geometric Coefficient of Variation 20.19
|
12.6147 Hours*micrograms per milliliter
Geometric Coefficient of Variation 19.75
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dosePopulation: PK Parameter BE Summary Population
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.
Outcome measures
| Measure |
A: DTG 50 mg + EPIVIR 300 mg
n=74 Participants
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
n=74 Participants
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
|
Part 2- A: DTG 50 mg + EPIVIR 300 mg
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
|
|---|---|---|---|---|---|---|
|
AUC(0-t) of Plasma DTG and 3TC in the Fasted State: Part 2
DTG
|
45.2043 Hour*microgram/milliliter
Geometric Coefficient of Variation 39.57
|
52.3372 Hour*microgram/milliliter
Geometric Coefficient of Variation 31.46
|
—
|
—
|
—
|
—
|
|
AUC(0-t) of Plasma DTG and 3TC in the Fasted State: Part 2
3TC
|
12.4790 Hour*microgram/milliliter
Geometric Coefficient of Variation 19.19
|
13.3552 Hour*microgram/milliliter
Geometric Coefficient of Variation 18.10
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dosePopulation: PK Parameter BE Summary Population
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Outcome measures
| Measure |
A: DTG 50 mg + EPIVIR 300 mg
n=73 Participants
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
n=73 Participants
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
|
Part 2- A: DTG 50 mg + EPIVIR 300 mg
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
|
|---|---|---|---|---|---|---|
|
Maximum Observed Concentration (Cmax) of Plasma DTG and 3TC in the Fasted State: Part 1
DTG
|
2.4065 Micrograms per milliliter
Geometric Coefficient of Variation 38.95
|
3.0817 Micrograms per milliliter
Geometric Coefficient of Variation 31.86
|
—
|
—
|
—
|
—
|
|
Maximum Observed Concentration (Cmax) of Plasma DTG and 3TC in the Fasted State: Part 1
3TC
|
2.6650 Micrograms per milliliter
Geometric Coefficient of Variation 29.04
|
3.1885 Micrograms per milliliter
Geometric Coefficient of Variation 28.07
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dosePopulation: PK Parameter BE Summary Population
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.
Outcome measures
| Measure |
A: DTG 50 mg + EPIVIR 300 mg
n=74 Participants
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
n=74 Participants
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
|
Part 2- A: DTG 50 mg + EPIVIR 300 mg
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
|
|---|---|---|---|---|---|---|
|
Cmax of Plasma DTG and 3TC in the Fasted State: Part 2
DTG
|
2.5531 Micrograms per milliliter
Geometric Coefficient of Variation 36.38
|
2.9132 Micrograms per milliliter
Geometric Coefficient of Variation 30.55
|
—
|
—
|
—
|
—
|
|
Cmax of Plasma DTG and 3TC in the Fasted State: Part 2
3TC
|
2.4428 Micrograms per milliliter
Geometric Coefficient of Variation 28.25
|
3.2185 Micrograms per milliliter
Geometric Coefficient of Variation 29.30
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dosePopulation: PK Parameter BE Summary Population
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Outcome measures
| Measure |
A: DTG 50 mg + EPIVIR 300 mg
n=73 Participants
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
n=73 Participants
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
|
Part 2- A: DTG 50 mg + EPIVIR 300 mg
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
|
|---|---|---|---|---|---|---|
|
Absorption Lag Time (Tlag) of DTG and 3TC in Fasted State: Part 1
DTG
|
0.0000 Hour
Interval 0.0 to 0.756
|
0.0000 Hour
Interval 0.0 to 0.261
|
—
|
—
|
—
|
—
|
|
Absorption Lag Time (Tlag) of DTG and 3TC in Fasted State: Part 1
3TC
|
0.0000 Hour
Interval 0.0 to 0.252
|
0.0000 Hour
Interval 0.0 to 0.261
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dosePopulation: PK Parameter BE Summary Population
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.
Outcome measures
| Measure |
A: DTG 50 mg + EPIVIR 300 mg
n=74 Participants
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
n=74 Participants
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
|
Part 2- A: DTG 50 mg + EPIVIR 300 mg
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
|
|---|---|---|---|---|---|---|
|
Tlag of DTG and 3TC in Fasted State: Part 2
DTG
|
0.0000 Hour
Interval 0.0 to 0.261
|
0.0000 Hour
Interval 0.0 to 0.266
|
—
|
—
|
—
|
—
|
|
Tlag of DTG and 3TC in Fasted State: Part 2
3TC
|
0.0000 Hour
Interval 0.0 to 0.0
|
0.0000 Hour
Interval 0.0 to 0.252
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dosePopulation: PK Parameter BE Summary Population.
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Outcome measures
| Measure |
A: DTG 50 mg + EPIVIR 300 mg
n=73 Participants
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
n=73 Participants
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
|
Part 2- A: DTG 50 mg + EPIVIR 300 mg
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
|
|---|---|---|---|---|---|---|
|
Time to Reach Maximum Plasma Concentration (Tmax) of DTG and 3TC in the Fasted State: Part 1
DTG
|
2.0072 Hour
Interval 0.5 to 8.009
|
2.0017 Hour
Interval 0.5 to 5.012
|
—
|
—
|
—
|
—
|
|
Time to Reach Maximum Plasma Concentration (Tmax) of DTG and 3TC in the Fasted State: Part 1
3TC
|
1.0047 Hour
Interval 0.5 to 4.005
|
1.0008 Hour
Interval 0.5 to 3.5
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dosePopulation: PK Parameter BE Summary Population
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2
Outcome measures
| Measure |
A: DTG 50 mg + EPIVIR 300 mg
n=74 Participants
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
n=74 Participants
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
|
Part 2- A: DTG 50 mg + EPIVIR 300 mg
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
|
|---|---|---|---|---|---|---|
|
Tmax of DTG and 3TC in the Fasted State: Part 2
DTG
|
2.5008 Hour
Interval 0.5 to 5.011
|
2.5004 Hour
Interval 0.5 to 6.001
|
—
|
—
|
—
|
—
|
|
Tmax of DTG and 3TC in the Fasted State: Part 2
3TC
|
1.0063 Hour
Interval 0.5 to 4.002
|
1.0011 Hour
Interval 0.5 to 3.501
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dosePopulation: PK Parameter BE Summary Population
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Outcome measures
| Measure |
A: DTG 50 mg + EPIVIR 300 mg
n=73 Participants
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
n=73 Participants
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
|
Part 2- A: DTG 50 mg + EPIVIR 300 mg
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
|
|---|---|---|---|---|---|---|
|
Time of the Last Quantifiable Concentration (Tlast) of DTG and 3TC in the Fasted State: Part 1
DTG
|
72.0031 Hour
Interval 48.0 to 74.636
|
71.9303 Hour
Interval 48.003 to 76.236
|
—
|
—
|
—
|
—
|
|
Time of the Last Quantifiable Concentration (Tlast) of DTG and 3TC in the Fasted State: Part 1
3TC
|
71.9289 Hour
Interval 47.673 to 74.636
|
71.9303 Hour
Interval 70.79 to 76.236
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dosePopulation: PK Parameter BE Summary Population
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2
Outcome measures
| Measure |
A: DTG 50 mg + EPIVIR 300 mg
n=74 Participants
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
n=74 Participants
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
|
Part 2- A: DTG 50 mg + EPIVIR 300 mg
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
|
|---|---|---|---|---|---|---|
|
Tlast of DTG and 3TC in the Fasted State: Part 2
DTG
|
71.6813 Hour
Interval 48.006 to 75.301
|
71.8243 Hour
Interval 71.005 to 72.632
|
—
|
—
|
—
|
—
|
|
Tlast of DTG and 3TC in the Fasted State: Part 2
3TC
|
71.7138 Hour
Interval 48.0 to 75.301
|
71.8153 Hour
Interval 48.007 to 72.632
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dosePopulation: PK Parameter BE Summary Population
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Outcome measures
| Measure |
A: DTG 50 mg + EPIVIR 300 mg
n=73 Participants
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
n=73 Participants
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
|
Part 2- A: DTG 50 mg + EPIVIR 300 mg
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
|
|---|---|---|---|---|---|---|
|
Time to Reach Half the Maximum Plasma Concentration (t1/2) of DTG and 3TC in the Fasted State: Part 1
DTG
|
14.6917 Hour
Interval 10.575 to 21.375
|
14.7557 Hour
Interval 10.461 to 21.392
|
—
|
—
|
—
|
—
|
|
Time to Reach Half the Maximum Plasma Concentration (t1/2) of DTG and 3TC in the Fasted State: Part 1
3TC
|
17.0395 Hour
Interval 8.281 to 34.542
|
17.3436 Hour
Interval 12.436 to 34.675
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dosePopulation: PK Parameter BE Summary Population. Only those participants with data available at the specified time points were analyzed indicated by n=X in category titles.
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2
Outcome measures
| Measure |
A: DTG 50 mg + EPIVIR 300 mg
n=74 Participants
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
n=74 Participants
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
|
Part 2- A: DTG 50 mg + EPIVIR 300 mg
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
|
|---|---|---|---|---|---|---|
|
t1/2 of DTG and 3TC in the Fasted State: Part 2
DTG, n= 74,74
|
15.1538 Hour
Interval 9.711 to 21.966
|
14.7893 Hour
Interval 9.815 to 21.486
|
—
|
—
|
—
|
—
|
|
t1/2 of DTG and 3TC in the Fasted State: Part 2
3TC, n= 73,74
|
17.8421 Hour
Interval 10.195 to 47.171
|
18.1071 Hour
Interval 7.367 to 48.613
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dosePopulation: PK Parameter BE Summary Population
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Outcome measures
| Measure |
A: DTG 50 mg + EPIVIR 300 mg
n=73 Participants
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
n=73 Participants
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
|
Part 2- A: DTG 50 mg + EPIVIR 300 mg
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
|
|---|---|---|---|---|---|---|
|
Apparent Elimination Rate Constant (Lambda z) of DTG and 3TC in the Fasted State: Part 1
DTG
|
0.0472 Per hour
Interval 0.032 to 0.066
|
0.0470 Per hour
Interval 0.032 to 0.066
|
—
|
—
|
—
|
—
|
|
Apparent Elimination Rate Constant (Lambda z) of DTG and 3TC in the Fasted State: Part 1
3TC
|
0.0407 Per hour
Interval 0.02 to 0.084
|
0.0400 Per hour
Interval 0.02 to 0.056
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dosePopulation: PK Parameter BE Summary Population. Only those participants with data available at the specified data points were analyzed (represented by n= X,X in the category titles).
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.
Outcome measures
| Measure |
A: DTG 50 mg + EPIVIR 300 mg
n=74 Participants
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
n=74 Participants
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
|
Part 2- A: DTG 50 mg + EPIVIR 300 mg
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
|
|---|---|---|---|---|---|---|
|
Lambda z of DTG and 3TC in in the Fasted State: Part 2
DTG, n=74,74
|
0.0457 Per hour
Interval 0.032 to 0.071
|
0.0469 Per hour
Interval 0.032 to 0.071
|
—
|
—
|
—
|
—
|
|
Lambda z of DTG and 3TC in in the Fasted State: Part 2
3TC, n= 73,74
|
0.0388 Per hour
Interval 0.015 to 0.068
|
0.0383 Per hour
Interval 0.014 to 0.094
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dosePopulation: PK Parameter BE Summary Population.
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Outcome measures
| Measure |
A: DTG 50 mg + EPIVIR 300 mg
n=73 Participants
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
n=73 Participants
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
|
Part 2- A: DTG 50 mg + EPIVIR 300 mg
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
|
|---|---|---|---|---|---|---|
|
Percentage of Extrapolated AUC (0 to Inf) of DTG and 3TC in the Fasted State: Part 1
DTG
|
3.4967 Percentage of AUC
Interval 1.015 to 15.084
|
3.2582 Percentage of AUC
Interval 0.908 to 9.967
|
—
|
—
|
—
|
—
|
|
Percentage of Extrapolated AUC (0 to Inf) of DTG and 3TC in the Fasted State: Part 1
3TC
|
1.0287 Percentage of AUC
Interval 0.343 to 7.305
|
0.9052 Percentage of AUC
Interval 0.428 to 5.334
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dosePopulation: PK Parameter BE Summary Population. Only those participants with data available at the specified time points were analyzed indicated by n=X in category titles.
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.
Outcome measures
| Measure |
A: DTG 50 mg + EPIVIR 300 mg
n=74 Participants
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
n=74 Participants
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
|
Part 2- A: DTG 50 mg + EPIVIR 300 mg
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
|
|---|---|---|---|---|---|---|
|
Percentage of Extrapolated AUC(0 to Inf) of DTG and 3TC in the Fasted State: Part 2
DTG, n= 74,74
|
3.8923 Percentage of AUC
Interval 0.932 to 10.512
|
3.5773 Percentage of AUC
Interval 0.659 to 9.57
|
—
|
—
|
—
|
—
|
|
Percentage of Extrapolated AUC(0 to Inf) of DTG and 3TC in the Fasted State: Part 2
3TC, n= 73,74
|
1.2518 Percentage of AUC
Interval 0.344 to 6.409
|
1.1432 Percentage of AUC
Interval 0.394 to 7.867
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dosePopulation: PK Parameter BE Summary Population
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Outcome measures
| Measure |
A: DTG 50 mg + EPIVIR 300 mg
n=73 Participants
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
n=73 Participants
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
|
Part 2- A: DTG 50 mg + EPIVIR 300 mg
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
|
|---|---|---|---|---|---|---|
|
AUC of 0 to 24 Hours (AUC[0-24]) of DTG and 3TC in the Fasted State: Part 1
DTG
|
29.4257 Hours*microgram per milliliter
Geometric Coefficient of Variation 38.40
|
37.6112 Hours*microgram per milliliter
Geometric Coefficient of Variation 30.28
|
—
|
—
|
—
|
—
|
|
AUC of 0 to 24 Hours (AUC[0-24]) of DTG and 3TC in the Fasted State: Part 1
3TC
|
11.3960 Hours*microgram per milliliter
Geometric Coefficient of Variation 20.92
|
11.9418 Hours*microgram per milliliter
Geometric Coefficient of Variation 20.09
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dosePopulation: PK Parameter BE Summary Population
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.
Outcome measures
| Measure |
A: DTG 50 mg + EPIVIR 300 mg
n=74 Participants
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
n=74 Participants
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
|
Part 2- A: DTG 50 mg + EPIVIR 300 mg
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
|
|---|---|---|---|---|---|---|
|
AUC(0-24) of DTG and 3TC in the Fasted State: Part 2
DTG
|
31.5664 Hours*microgram per milliliter
Geometric Coefficient of Variation 37.73
|
36.6126 Hours*microgram per milliliter
Geometric Coefficient of Variation 30.93
|
—
|
—
|
—
|
—
|
|
AUC(0-24) of DTG and 3TC in the Fasted State: Part 2
3TC
|
11.6419 Hours*microgram per milliliter
Geometric Coefficient of Variation 20.23
|
12.5810 Hours*microgram per milliliter
Geometric Coefficient of Variation 18.50
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dosePopulation: PK Parameter BE Summary Population
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Outcome measures
| Measure |
A: DTG 50 mg + EPIVIR 300 mg
n=73 Participants
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
n=73 Participants
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
|
Part 2- A: DTG 50 mg + EPIVIR 300 mg
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
|
|---|---|---|---|---|---|---|
|
Apparent Oral Clearance (CL/F) of DTG and 3TC in the Fasted State: Part 1
DTG
|
1.1589 Liters per hour
Geometric Coefficient of Variation 39.29
|
0.9111 Liters per hour
Geometric Coefficient of Variation 31.60
|
—
|
—
|
—
|
—
|
|
Apparent Oral Clearance (CL/F) of DTG and 3TC in the Fasted State: Part 1
3TC
|
24.3236 Liters per hour
Geometric Coefficient of Variation 19.88
|
23.5104 Liters per hour
Geometric Coefficient of Variation 19.77
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dosePopulation: PK Parameter BE Summary Population. Only those participants with data available at the specified time points were analyzed represented by n=X in the category titles.
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.
Outcome measures
| Measure |
A: DTG 50 mg + EPIVIR 300 mg
n=74 Participants
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
n=74 Participants
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
|
Part 2- A: DTG 50 mg + EPIVIR 300 mg
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
|
|---|---|---|---|---|---|---|
|
CL/F of DTG and 3TC in the Fasted State: Part 2
DTG, n= 74, 74
|
1.0584 Liters per hour
Geometric Coefficient of Variation 40.29
|
0.9164 Liters per hour
Geometric Coefficient of Variation 32.12
|
—
|
—
|
—
|
—
|
|
CL/F of DTG and 3TC in the Fasted State: Part 2
3TC, n= 73, 74
|
23.4901 Liters per hour
Geometric Coefficient of Variation 18.63
|
22.1200 Liters per hour
Geometric Coefficient of Variation 17.94
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dosePopulation: PK Parameter BE Summary Population
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Outcome measures
| Measure |
A: DTG 50 mg + EPIVIR 300 mg
n=73 Participants
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
n=73 Participants
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
|
Part 2- A: DTG 50 mg + EPIVIR 300 mg
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
|
|---|---|---|---|---|---|---|
|
Apparent Oral Volume of Distribution (Vz/F) of DTG and 3TC in the Fasted State: Part 1
DTG
|
24.6254 Liters
Geometric Coefficient of Variation 37.80
|
19.3399 Liters
Geometric Coefficient of Variation 30.05
|
—
|
—
|
—
|
—
|
|
Apparent Oral Volume of Distribution (Vz/F) of DTG and 3TC in the Fasted State: Part 1
3TC
|
616.7365 Liters
Geometric Coefficient of Variation 34.52
|
598.8651 Liters
Geometric Coefficient of Variation 29.07
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dosePopulation: PK Parameter BE Summary Population. Only those participants with data available at the specified data points were analyzed, represented by n= X,X in the category titles.
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.
Outcome measures
| Measure |
A: DTG 50 mg + EPIVIR 300 mg
n=74 Participants
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
n=74 Participants
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
|
Part 2- A: DTG 50 mg + EPIVIR 300 mg
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
|
|---|---|---|---|---|---|---|
|
Vz/F of DTG and 3TC in the Fasted State: Part 2
DTG, n= 74, 74
|
23.1159 Liters
Geometric Coefficient of Variation 37.18
|
19.8124 Liters
Geometric Coefficient of Variation 32.73
|
—
|
—
|
—
|
—
|
|
Vz/F of DTG and 3TC in the Fasted State: Part 2
3TC, n= 73, 74
|
650.7952 Liters
Geometric Coefficient of Variation 35.55
|
599.5525 Liters
Geometric Coefficient of Variation 34.28
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dosePopulation: PK Parameter BE Summary Population.
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Outcome measures
| Measure |
A: DTG 50 mg + EPIVIR 300 mg
n=73 Participants
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
n=73 Participants
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
|
Part 2- A: DTG 50 mg + EPIVIR 300 mg
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
|
|---|---|---|---|---|---|---|
|
Concentration at 24 Hours Post-dose (C24) of DTG and 3TC in the Fasted State: Part 1
DTG
|
0.6373 Micrograms per milliliter
Geometric Coefficient of Variation 40.18
|
0.8059 Micrograms per milliliter
Geometric Coefficient of Variation 32.77
|
—
|
—
|
—
|
—
|
|
Concentration at 24 Hours Post-dose (C24) of DTG and 3TC in the Fasted State: Part 1
3TC
|
0.0331 Micrograms per milliliter
Geometric Coefficient of Variation 32.13
|
0.0318 Micrograms per milliliter
Geometric Coefficient of Variation 31.81
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dosePopulation: PK Parameter BE Summary Population
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.
Outcome measures
| Measure |
A: DTG 50 mg + EPIVIR 300 mg
n=74 Participants
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
n=74 Participants
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
|
Part 2- A: DTG 50 mg + EPIVIR 300 mg
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
|
|---|---|---|---|---|---|---|
|
C24 of DTG and 3TC in the Fasted State: Part 2
DTG
|
0.7065 Micrograms per milliliter
Geometric Coefficient of Variation 41.48
|
0.8071 Micrograms per milliliter
Geometric Coefficient of Variation 33.83
|
—
|
—
|
—
|
—
|
|
C24 of DTG and 3TC in the Fasted State: Part 2
3TC
|
0.0366 Micrograms per milliliter
Geometric Coefficient of Variation 30.39
|
0.0350 Micrograms per milliliter
Geometric Coefficient of Variation 31.19
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dosePopulation: PK Parameter BE Summary Population
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Outcome measures
| Measure |
A: DTG 50 mg + EPIVIR 300 mg
n=73 Participants
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
n=73 Participants
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
|
Part 2- A: DTG 50 mg + EPIVIR 300 mg
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
|
|---|---|---|---|---|---|---|
|
Last Quantifiable Concentration (Clast) of DTG and 3TC in the Fasted State: Part 1
DTG
|
0.0702 Micrograms per milliliter
Geometric Coefficient of Variation 58.85
|
0.0832 Micrograms per milliliter
Geometric Coefficient of Variation 56.42
|
—
|
—
|
—
|
—
|
|
Last Quantifiable Concentration (Clast) of DTG and 3TC in the Fasted State: Part 1
3TC
|
0.0056 Micrograms per milliliter
Geometric Coefficient of Variation 43.03
|
0.0050 Micrograms per milliliter
Geometric Coefficient of Variation 37.58
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dosePopulation: PK Parameter BE Summary Population
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.
Outcome measures
| Measure |
A: DTG 50 mg + EPIVIR 300 mg
n=74 Participants
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
n=74 Participants
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
|
Part 2- A: DTG 50 mg + EPIVIR 300 mg
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
|
|---|---|---|---|---|---|---|
|
Clast of DTG and 3TC in the Fasted State: Part 2
DTG
|
0.0800 Micrograms per milliliter
Geometric Coefficient of Variation 66.94
|
0.0862 Micrograms per milliliter
Geometric Coefficient of Variation 65.26
|
—
|
—
|
—
|
—
|
|
Clast of DTG and 3TC in the Fasted State: Part 2
3TC
|
0.0069 Micrograms per milliliter
Geometric Coefficient of Variation 47.83
|
0.0062 Micrograms per milliliter
Geometric Coefficient of Variation 41.60
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dosePopulation: PK Parameter food effect (FD) Summary Population comprised of participants who participated in the food effect part of the study and had evaluable PK parameters for both fed and fasted administration of the FDC tablet formulation.
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
Outcome measures
| Measure |
A: DTG 50 mg + EPIVIR 300 mg
n=16 Participants
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
n=16 Participants
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
|
Part 2- A: DTG 50 mg + EPIVIR 300 mg
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
|
|---|---|---|---|---|---|---|
|
AUC (0-Inf) of Plasma DTG and 3TC in the Fed State: Part 1
DTG
|
62.3435 Hours*microgram per milliliter
Geometric Coefficient of Variation 32.34
|
71.9777 Hours*microgram per milliliter
Geometric Coefficient of Variation 19.99
|
—
|
—
|
—
|
—
|
|
AUC (0-Inf) of Plasma DTG and 3TC in the Fed State: Part 1
3TC
|
13.4357 Hours*microgram per milliliter
Geometric Coefficient of Variation 21.02
|
12.8668 Hours*microgram per milliliter
Geometric Coefficient of Variation 18.50
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dosePopulation: PK Parameter FD Summary Population
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Outcome measures
| Measure |
A: DTG 50 mg + EPIVIR 300 mg
n=16 Participants
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
n=16 Participants
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
|
Part 2- A: DTG 50 mg + EPIVIR 300 mg
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
|
|---|---|---|---|---|---|---|
|
AUC (0-Inf) of Plasma DTG and 3TC in the Fed State: Part 2
DTG
|
57.6561 Hours*microgram per milliliter
Geometric Coefficient of Variation 35.93
|
76.4283 Hours*microgram per milliliter
Geometric Coefficient of Variation 22.36
|
—
|
—
|
—
|
—
|
|
AUC (0-Inf) of Plasma DTG and 3TC in the Fed State: Part 2
3TC
|
14.6420 Hours*microgram per milliliter
Geometric Coefficient of Variation 18.50
|
13.3443 Hours*microgram per milliliter
Geometric Coefficient of Variation 20.34
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dosePopulation: PK Parameter FD Summary Population
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
Outcome measures
| Measure |
A: DTG 50 mg + EPIVIR 300 mg
n=16 Participants
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
n=16 Participants
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
|
Part 2- A: DTG 50 mg + EPIVIR 300 mg
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
|
|---|---|---|---|---|---|---|
|
AUC (0-t) of Plasma DTG and 3TC in the Fed State: Part 1
DTG
|
60.3212 Hour*microgram per milliliter
Geometric Coefficient of Variation 31.78
|
69.2560 Hour*microgram per milliliter
Geometric Coefficient of Variation 18.92
|
—
|
—
|
—
|
—
|
|
AUC (0-t) of Plasma DTG and 3TC in the Fed State: Part 1
3TC
|
13.2818 Hour*microgram per milliliter
Geometric Coefficient of Variation 20.90
|
12.6491 Hour*microgram per milliliter
Geometric Coefficient of Variation 18.63
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dosePopulation: PK Parameter FD Summary Population
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Outcome measures
| Measure |
A: DTG 50 mg + EPIVIR 300 mg
n=16 Participants
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
n=16 Participants
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
|
Part 2- A: DTG 50 mg + EPIVIR 300 mg
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
|
|---|---|---|---|---|---|---|
|
AUC (0-t) of Plasma DTG and 3TC in the Fed State: Part 2
DTG
|
55.2176 Hour*microgram per milliliter
Geometric Coefficient of Variation 35.33
|
72.7545 Hour*microgram per milliliter
Geometric Coefficient of Variation 20.22
|
—
|
—
|
—
|
—
|
|
AUC (0-t) of Plasma DTG and 3TC in the Fed State: Part 2
3TC
|
14.4706 Hour*microgram per milliliter
Geometric Coefficient of Variation 18.72
|
13.0923 Hour*microgram per milliliter
Geometric Coefficient of Variation 20.57
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dosePopulation: PK Parameter FD Summary Population
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
Outcome measures
| Measure |
A: DTG 50 mg + EPIVIR 300 mg
n=16 Participants
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
n=16 Participants
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
|
Part 2- A: DTG 50 mg + EPIVIR 300 mg
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
|
|---|---|---|---|---|---|---|
|
Cmax of Plasma DTG and 3TC in the Fed State: Part 1
DTG
|
3.5068 Micrograms per milliliter
Geometric Coefficient of Variation 30.27
|
3.7900 Micrograms per milliliter
Geometric Coefficient of Variation 20.97
|
—
|
—
|
—
|
—
|
|
Cmax of Plasma DTG and 3TC in the Fed State: Part 1
3TC
|
3.5413 Micrograms per milliliter
Geometric Coefficient of Variation 27.14
|
2.5132 Micrograms per milliliter
Geometric Coefficient of Variation 18.74
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dosePopulation: PK Parameter FD Summary Population
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Outcome measures
| Measure |
A: DTG 50 mg + EPIVIR 300 mg
n=16 Participants
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
n=16 Participants
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
|
Part 2- A: DTG 50 mg + EPIVIR 300 mg
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
|
|---|---|---|---|---|---|---|
|
Cmax of Plasma DTG and 3TC in the Fed State: Part 2
DTG
|
3.1015 Micrograms per milliliter
Geometric Coefficient of Variation 35.62
|
3.7516 Micrograms per milliliter
Geometric Coefficient of Variation 21.31
|
—
|
—
|
—
|
—
|
|
Cmax of Plasma DTG and 3TC in the Fed State: Part 2
3TC
|
3.5824 Micrograms per milliliter
Geometric Coefficient of Variation 35.18
|
2.4453 Micrograms per milliliter
Geometric Coefficient of Variation 33.88
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dosePopulation: PK Parameter FD Summary Population
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
Outcome measures
| Measure |
A: DTG 50 mg + EPIVIR 300 mg
n=16 Participants
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
n=16 Participants
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
|
Part 2- A: DTG 50 mg + EPIVIR 300 mg
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
|
|---|---|---|---|---|---|---|
|
Tlag of DTG and 3TC in Fed State: Part 1
DTG
|
0.0000 Hour
Interval 0.0 to 0.251
|
0.2522 Hour
Interval 0.0 to 1.0
|
—
|
—
|
—
|
—
|
|
Tlag of DTG and 3TC in Fed State: Part 1
3TC
|
0.0000 Hour
Interval 0.0 to 0.251
|
0.0000 Hour
Interval 0.0 to 0.255
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dosePopulation: PK Parameter FD Summary Population
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Outcome measures
| Measure |
A: DTG 50 mg + EPIVIR 300 mg
n=16 Participants
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
n=16 Participants
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
|
Part 2- A: DTG 50 mg + EPIVIR 300 mg
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
|
|---|---|---|---|---|---|---|
|
Tlag of DTG and 3TC in Fed State: Part 2
DTG
|
0.0000 Hour
Interval 0.0 to 0.258
|
0.1253 Hour
Interval 0.0 to 0.751
|
—
|
—
|
—
|
—
|
|
Tlag of DTG and 3TC in Fed State: Part 2
3TC
|
0.0000 Hour
Interval 0.0 to 0.252
|
0.0000 Hour
Interval 0.0 to 0.257
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dosePopulation: PK Parameter FD Summary Population
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
Outcome measures
| Measure |
A: DTG 50 mg + EPIVIR 300 mg
n=16 Participants
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
n=16 Participants
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
|
Part 2- A: DTG 50 mg + EPIVIR 300 mg
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
|
|---|---|---|---|---|---|---|
|
Tmax of DTG and 3TC in the Fed State: Part 1
DTG
|
1.5013 Hour
Interval 0.503 to 5.002
|
5.0006 Hour
Interval 2.001 to 12.009
|
—
|
—
|
—
|
—
|
|
Tmax of DTG and 3TC in the Fed State: Part 1
3TC
|
1.0001 Hour
Interval 0.5 to 2.001
|
3.5003 Hour
Interval 1.011 to 5.006
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dosePopulation: PK Parameter FD Summary Population
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Outcome measures
| Measure |
A: DTG 50 mg + EPIVIR 300 mg
n=16 Participants
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
n=16 Participants
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
|
Part 2- A: DTG 50 mg + EPIVIR 300 mg
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
|
|---|---|---|---|---|---|---|
|
Tmax of DTG and 3TC in the Fed State: Part 2
DTG
|
1.5007 Hour
Interval 0.751 to 3.001
|
5.0019 Hour
Interval 1.011 to 8.004
|
—
|
—
|
—
|
—
|
|
Tmax of DTG and 3TC in the Fed State: Part 2
3TC
|
1.0003 Hour
Interval 0.503 to 2.506
|
2.7508 Hour
Interval 1.001 to 6.001
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dosePopulation: PK Parameter FD Summary Population
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
Outcome measures
| Measure |
A: DTG 50 mg + EPIVIR 300 mg
n=16 Participants
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
n=16 Participants
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
|
Part 2- A: DTG 50 mg + EPIVIR 300 mg
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
|
|---|---|---|---|---|---|---|
|
T1/2 of DTG and 3TC in the Fed State: Part 1
DTG
|
14.5843 Hour
Interval 12.077 to 16.806
|
14.5816 Hour
Interval 10.889 to 17.259
|
—
|
—
|
—
|
—
|
|
T1/2 of DTG and 3TC in the Fed State: Part 1
3TC
|
18.3614 Hour
Interval 12.509 to 30.759
|
19.8579 Hour
Interval 9.977 to 34.144
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dosePopulation: PK Parameter FD Summary Population
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Outcome measures
| Measure |
A: DTG 50 mg + EPIVIR 300 mg
n=16 Participants
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
n=16 Participants
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
|
Part 2- A: DTG 50 mg + EPIVIR 300 mg
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
|
|---|---|---|---|---|---|---|
|
T1/2 of DTG and 3TC in the Fed State: Part 2
DTG
|
14.9828 Hour
Interval 11.355 to 20.563
|
15.1718 Hour
Interval 12.193 to 19.945
|
—
|
—
|
—
|
—
|
|
T1/2 of DTG and 3TC in the Fed State: Part 2
3TC
|
17.2250 Hour
Interval 13.259 to 37.099
|
19.7311 Hour
Interval 13.384 to 27.781
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dosePopulation: PK Parameter FD Summary Population
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
Outcome measures
| Measure |
A: DTG 50 mg + EPIVIR 300 mg
n=16 Participants
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
n=16 Participants
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
|
Part 2- A: DTG 50 mg + EPIVIR 300 mg
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
|
|---|---|---|---|---|---|---|
|
Lambda z of DTG and 3TC in in the Fed State: Part 1
DTG
|
0.0475 Per hour
Interval 0.041 to 0.057
|
0.0475 Per hour
Interval 0.04 to 0.064
|
—
|
—
|
—
|
—
|
|
Lambda z of DTG and 3TC in in the Fed State: Part 1
3TC
|
0.0378 Per hour
Interval 0.023 to 0.055
|
0.0349 Per hour
Interval 0.02 to 0.069
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dosePopulation: PK Parameter FD Summary Population
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Outcome measures
| Measure |
A: DTG 50 mg + EPIVIR 300 mg
n=16 Participants
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
n=16 Participants
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
|
Part 2- A: DTG 50 mg + EPIVIR 300 mg
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
|
|---|---|---|---|---|---|---|
|
Lambda z of DTG and 3TC in in the Fed State: Part 2
DTG
|
0.0463 Per hour
Interval 0.034 to 0.061
|
0.0457 Per hour
Interval 0.035 to 0.057
|
—
|
—
|
—
|
—
|
|
Lambda z of DTG and 3TC in in the Fed State: Part 2
3TC
|
0.0403 Per hour
Interval 0.019 to 0.052
|
0.0351 Per hour
Interval 0.025 to 0.052
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dosePopulation: PK Parameter FD Summary Population
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
Outcome measures
| Measure |
A: DTG 50 mg + EPIVIR 300 mg
n=16 Participants
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
n=16 Participants
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
|
Part 2- A: DTG 50 mg + EPIVIR 300 mg
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
|
|---|---|---|---|---|---|---|
|
Clast of DTG and 3TC in in the Fed State: Part 1
DTG
|
0.1060 Micrograms per milliliter
Interval 0.035 to 0.18
|
0.1190 Micrograms per milliliter
Interval 0.043 to 0.243
|
—
|
—
|
—
|
—
|
|
Clast of DTG and 3TC in in the Fed State: Part 1
3TC
|
0.0048 Micrograms per milliliter
Interval 0.003 to 0.014
|
0.0066 Micrograms per milliliter
Interval 0.004 to 0.016
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dosePopulation: PK Parameter FD Summary Population
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Outcome measures
| Measure |
A: DTG 50 mg + EPIVIR 300 mg
n=16 Participants
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
n=16 Participants
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
|
Part 2- A: DTG 50 mg + EPIVIR 300 mg
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
|
|---|---|---|---|---|---|---|
|
Clast of DTG and 3TC in in the Fed State: Part 2
3TC
|
0.0059 Micrograms per milliliter
Interval 0.003 to 0.011
|
0.0091 Micrograms per milliliter
Interval 0.003 to 0.015
|
—
|
—
|
—
|
—
|
|
Clast of DTG and 3TC in in the Fed State: Part 2
DTG
|
0.0975 Micrograms per milliliter
Interval 0.031 to 0.24
|
0.1310 Micrograms per milliliter
Interval 0.051 to 0.363
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dosePopulation: PK Parameter FD Summary Population
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
Outcome measures
| Measure |
A: DTG 50 mg + EPIVIR 300 mg
n=16 Participants
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
n=16 Participants
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
|
Part 2- A: DTG 50 mg + EPIVIR 300 mg
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
|
|---|---|---|---|---|---|---|
|
Percentage of Extrapolated AUC (0-inf) in the Fed State: Part 1
DTG
|
3.3305 Percentage of AUC
Interval 1.49 to 4.845
|
3.8870 Percentage of AUC
Interval 1.094 to 6.134
|
—
|
—
|
—
|
—
|
|
Percentage of Extrapolated AUC (0-inf) in the Fed State: Part 1
3TC
|
0.8856 Percentage of AUC
Interval 0.561 to 3.51
|
1.4830 Percentage of AUC
Interval 0.788 to 4.324
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dosePopulation: PK Parameter FD Summary Population
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Outcome measures
| Measure |
A: DTG 50 mg + EPIVIR 300 mg
n=16 Participants
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
n=16 Participants
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
|
Part 2- A: DTG 50 mg + EPIVIR 300 mg
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
|
|---|---|---|---|---|---|---|
|
Percentage of Extrapolated AUC (0-inf) in the Fed State: Part 2
DTG
|
3.6835 Percentage of AUC
Interval 1.069 to 8.601
|
3.8790 Percentage of AUC
Interval 1.561 to 9.126
|
—
|
—
|
—
|
—
|
|
Percentage of Extrapolated AUC (0-inf) in the Fed State: Part 2
3TC
|
1.0443 Percentage of AUC
Interval 0.467 to 3.859
|
1.7467 Percentage of AUC
Interval 0.567 to 3.642
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dosePopulation: PK Parameter FD Summary Population
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
Outcome measures
| Measure |
A: DTG 50 mg + EPIVIR 300 mg
n=16 Participants
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
n=16 Participants
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
|
Part 2- A: DTG 50 mg + EPIVIR 300 mg
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
|
|---|---|---|---|---|---|---|
|
AUC(0-24) of DTG and 3TC in the Fed State: Part 1
DTG
|
43.1879 Hour*microgram per milliliter
Geometric Coefficient of Variation 29.88
|
46.8555 Hour*microgram per milliliter
Geometric Coefficient of Variation 16.95
|
—
|
—
|
—
|
—
|
|
AUC(0-24) of DTG and 3TC in the Fed State: Part 1
3TC
|
12.6113 Hour*microgram per milliliter
Geometric Coefficient of Variation 21.25
|
11.8076 Hour*microgram per milliliter
Geometric Coefficient of Variation 18.71
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dosePopulation: PK Parameter FD Summary Population
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Outcome measures
| Measure |
A: DTG 50 mg + EPIVIR 300 mg
n=16 Participants
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
n=16 Participants
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
|
Part 2- A: DTG 50 mg + EPIVIR 300 mg
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
|
|---|---|---|---|---|---|---|
|
AUC(0-24) of DTG and 3TC in the Fed State: Part 2
DTG
|
38.6325 Hour*microgram per milliliter
Geometric Coefficient of Variation 34.53
|
48.2012 Hour*microgram per milliliter
Geometric Coefficient of Variation 15.53
|
—
|
—
|
—
|
—
|
|
AUC(0-24) of DTG and 3TC in the Fed State: Part 2
3TC
|
13.7012 Hour*microgram per milliliter
Geometric Coefficient of Variation 19.24
|
12.1065 Hour*microgram per milliliter
Geometric Coefficient of Variation 21.09
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dosePopulation: PK Parameter FD Summary Population
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
Outcome measures
| Measure |
A: DTG 50 mg + EPIVIR 300 mg
n=16 Participants
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
n=16 Participants
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
|
Part 2- A: DTG 50 mg + EPIVIR 300 mg
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
|
|---|---|---|---|---|---|---|
|
CL/F of DTG and 3TC in the Fed State: Part 1
DTG
|
0.8020 Liters per hour
Geometric Coefficient of Variation 32.34
|
0.6947 Liters per hour
Geometric Coefficient of Variation 19.99
|
—
|
—
|
—
|
—
|
|
CL/F of DTG and 3TC in the Fed State: Part 1
3TC
|
22.3285 Liters per hour
Geometric Coefficient of Variation 21.02
|
23.3159 Liters per hour
Geometric Coefficient of Variation 18.50
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dosePopulation: PK Parameter FD Summary Population
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Outcome measures
| Measure |
A: DTG 50 mg + EPIVIR 300 mg
n=16 Participants
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
n=16 Participants
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
|
Part 2- A: DTG 50 mg + EPIVIR 300 mg
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
|
|---|---|---|---|---|---|---|
|
CL/F of DTG and 3TC in the Fed State: Part 2
DTG
|
0.8672 Liters per hour
Geometric Coefficient of Variation 35.93
|
0.6542 Liters per hour
Geometric Coefficient of Variation 22.36
|
—
|
—
|
—
|
—
|
|
CL/F of DTG and 3TC in the Fed State: Part 2
3TC
|
20.4890 Liters per hour
Geometric Coefficient of Variation 18.50
|
22.4815 Liters per hour
Geometric Coefficient of Variation 20.34
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dosePopulation: PK Parameter FD Summary Population
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
Outcome measures
| Measure |
A: DTG 50 mg + EPIVIR 300 mg
n=16 Participants
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
n=16 Participants
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
|
Part 2- A: DTG 50 mg + EPIVIR 300 mg
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
|
|---|---|---|---|---|---|---|
|
Tlast of DTG and 3TC in the Fed State: Part 1
DTG
|
71.8265 Hours
Interval 71.124 to 72.301
|
71.9758 Hours
Interval 71.33 to 72.869
|
—
|
—
|
—
|
—
|
|
Tlast of DTG and 3TC in the Fed State: Part 1
3TC
|
71.8265 Hours
Interval 71.124 to 72.301
|
71.9758 Hours
Interval 71.33 to 72.869
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dosePopulation: PK Parameter FD Summary Population
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Outcome measures
| Measure |
A: DTG 50 mg + EPIVIR 300 mg
n=16 Participants
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
n=16 Participants
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
|
Part 2- A: DTG 50 mg + EPIVIR 300 mg
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
|
|---|---|---|---|---|---|---|
|
Tlast of DTG and 3TC in the Fed State: Part 2
DTG
|
72.0292 Hours
Interval 71.446 to 72.269
|
71.8711 Hours
Interval 71.08 to 72.381
|
—
|
—
|
—
|
—
|
|
Tlast of DTG and 3TC in the Fed State: Part 2
3TC
|
72.0292 Hours
Interval 71.446 to 72.269
|
71.8711 Hours
Interval 71.08 to 72.381
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dosePopulation: PK Parameter FD Summary Population.
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
Outcome measures
| Measure |
A: DTG 50 mg + EPIVIR 300 mg
n=16 Participants
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
n=16 Participants
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
|
Part 2- A: DTG 50 mg + EPIVIR 300 mg
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
|
|---|---|---|---|---|---|---|
|
Vz/F of DTG and 3TC in the Fed State: Part 1
DTG
|
16.7520 Liters
Geometric Coefficient of Variation 28.45
|
14.4964 Liters
Geometric Coefficient of Variation 15.87
|
—
|
—
|
—
|
—
|
|
Vz/F of DTG and 3TC in the Fed State: Part 1
3TC
|
593.2054 Liters
Geometric Coefficient of Variation 29.23
|
643.0977 Liters
Geometric Coefficient of Variation 41.08
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dosePopulation: PK Parameter FD Summary Population
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Outcome measures
| Measure |
A: DTG 50 mg + EPIVIR 300 mg
n=16 Participants
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
n=16 Participants
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
|
Part 2- A: DTG 50 mg + EPIVIR 300 mg
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
|
|---|---|---|---|---|---|---|
|
Vz/F of DTG and 3TC in the Fed State: Part 2
DTG
|
19.0954 Liters
Geometric Coefficient of Variation 36.45
|
14.6215 Liters
Geometric Coefficient of Variation 11.63
|
—
|
—
|
—
|
—
|
|
Vz/F of DTG and 3TC in the Fed State: Part 2
3TC
|
535.8125 Liters
Geometric Coefficient of Variation 35.63
|
641.3744 Liters
Geometric Coefficient of Variation 32.10
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dosePopulation: PK Parameter FD Summary Population
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
Outcome measures
| Measure |
A: DTG 50 mg + EPIVIR 300 mg
n=16 Participants
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
n=16 Participants
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
|
Part 2- A: DTG 50 mg + EPIVIR 300 mg
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
|
|---|---|---|---|---|---|---|
|
C24 of DTG and 3TC in the Fed State: Part 1
DTG
|
0.9216 Micrograms per milliliter
Geometric Coefficient of Variation 36.08
|
1.1916 Micrograms per milliliter
Geometric Coefficient of Variation 25.03
|
—
|
—
|
—
|
—
|
|
C24 of DTG and 3TC in the Fed State: Part 1
3TC
|
0.0304 Micrograms per milliliter
Geometric Coefficient of Variation 33.07
|
0.0366 Micrograms per milliliter
Geometric Coefficient of Variation 35.90
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dosePopulation: PK Parameter FD Summary Population
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Outcome measures
| Measure |
A: DTG 50 mg + EPIVIR 300 mg
n=16 Participants
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
n=16 Participants
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
|
Part 2- A: DTG 50 mg + EPIVIR 300 mg
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
|
|---|---|---|---|---|---|---|
|
C24 of DTG and 3TC in the Fed State: Part 2
DTG
|
0.8355 Micrograms per milliliter
Geometric Coefficient of Variation 38.46
|
1.2273 Micrograms per milliliter
Geometric Coefficient of Variation 25.73
|
—
|
—
|
—
|
—
|
|
C24 of DTG and 3TC in the Fed State: Part 2
3TC
|
0.0350 Micrograms per milliliter
Geometric Coefficient of Variation 39.91
|
0.0417 Micrograms per milliliter
Geometric Coefficient of Variation 38.62
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 31 in Part 1 and Part 2Population: Safety Population comprised of all participants who were enrolled in the study and received at least one dose of study drug. Only those participants available at the specified time points were analyzed represented by n=X,X,X,X,X,X in the category titles.
SBP and DBP were measured in the supine or semi-supine position after 5 minutes rest. The Baseline value was considered to be the participant's last available assessment prior to time of the first dose. Change from Baseline was defined as post dose visit value minus Baseline value. Data for SBP and DBP for Part 1 and 2 is presented.
Outcome measures
| Measure |
A: DTG 50 mg + EPIVIR 300 mg
n=75 Participants
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
n=76 Participants
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
n=16 Participants
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
|
Part 2- A: DTG 50 mg + EPIVIR 300 mg
n=75 Participants
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC
n=75 Participants
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
n=16 Participants
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Part 1 and 2
SBP,Day 3,n=74,75,16,75,75,16
|
4.0 Millimeters of mercury
Standard Deviation 6.67
|
2.7 Millimeters of mercury
Standard Deviation 6.15
|
2.9 Millimeters of mercury
Standard Deviation 4.84
|
1.9 Millimeters of mercury
Standard Deviation 7.28
|
1.6 Millimeters of mercury
Standard Deviation 7.50
|
2.3 Millimeters of mercury
Standard Deviation 7.73
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Part 1 and 2
DBP,4 hour,n=75,76,16,75,75,16
|
0.1 Millimeters of mercury
Standard Deviation 5.85
|
0.2 Millimeters of mercury
Standard Deviation 5.24
|
-2.1 Millimeters of mercury
Standard Deviation 4.19
|
-0.5 Millimeters of mercury
Standard Deviation 4.09
|
-0.3 Millimeters of mercury
Standard Deviation 5.71
|
0.0 Millimeters of mercury
Standard Deviation 4.86
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Part 1 and 2
DBP,Day 2,n=74,75,16,75,75,16
|
-0.3 Millimeters of mercury
Standard Deviation 5.53
|
-0.9 Millimeters of mercury
Standard Deviation 6.14
|
0.4 Millimeters of mercury
Standard Deviation 5.32
|
-1.7 Millimeters of mercury
Standard Deviation 4.87
|
-1.1 Millimeters of mercury
Standard Deviation 4.99
|
3.1 Millimeters of mercury
Standard Deviation 5.37
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Part 1 and 2
DBP,Day 3,n=74,75,16,75,75,16
|
3.2 Millimeters of mercury
Standard Deviation 6.83
|
2.7 Millimeters of mercury
Standard Deviation 5.95
|
1.3 Millimeters of mercury
Standard Deviation 5.19
|
1.7 Millimeters of mercury
Standard Deviation 5.74
|
1.2 Millimeters of mercury
Standard Deviation 6.09
|
3.4 Millimeters of mercury
Standard Deviation 5.76
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Part 1 and 2
DBP,Day 4,n=73,75,16,75,75,16
|
7.4 Millimeters of mercury
Standard Deviation 6.47
|
5.4 Millimeters of mercury
Standard Deviation 6.64
|
6.1 Millimeters of mercury
Standard Deviation 4.22
|
4.9 Millimeters of mercury
Standard Deviation 6.51
|
5.3 Millimeters of mercury
Standard Deviation 6.11
|
8.3 Millimeters of mercury
Standard Deviation 6.94
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Part 1 and 2
SBP,4 hour,n=75,76,16,75,75,16
|
1.5 Millimeters of mercury
Standard Deviation 6.12
|
0.6 Millimeters of mercury
Standard Deviation 5.94
|
-0.8 Millimeters of mercury
Standard Deviation 5.49
|
0.0 Millimeters of mercury
Standard Deviation 5.04
|
0.5 Millimeters of mercury
Standard Deviation 7.21
|
1.0 Millimeters of mercury
Standard Deviation 7.28
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Part 1 and 2
SBP,Day 2,n=74,75,16,75,75,16
|
-0.5 Millimeters of mercury
Standard Deviation 6.88
|
-1.4 Millimeters of mercury
Standard Deviation 6.05
|
0.4 Millimeters of mercury
Standard Deviation 3.91
|
-1.5 Millimeters of mercury
Standard Deviation 5.10
|
-1.7 Millimeters of mercury
Standard Deviation 7.12
|
1.9 Millimeters of mercury
Standard Deviation 8.06
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Part 1 and 2
SBP,Day 4,n=73,75,16,75,75,16
|
8.2 Millimeters of mercury
Standard Deviation 8.09
|
7.5 Millimeters of mercury
Standard Deviation 8.43
|
7.0 Millimeters of mercury
Standard Deviation 5.80
|
7.0 Millimeters of mercury
Standard Deviation 8.86
|
7.2 Millimeters of mercury
Standard Deviation 8.72
|
7.6 Millimeters of mercury
Standard Deviation 8.42
|
SECONDARY outcome
Timeframe: Up to Day 31 in Part 1 and Part 2Population: Safety Population. Only those participants available at the specified time points were analyzed represented by n=X,X,X,X,X,X in the category titles.
HR was measured in the supine or semi-supine position after 5 minutes rest. The Baseline value was considered to be the participant's last available assessment prior to time of the first dose. Change from Baseline was defined as post dose visit value minus Baseline value. Data for HR for Part 1 and 2 is presented.
Outcome measures
| Measure |
A: DTG 50 mg + EPIVIR 300 mg
n=75 Participants
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
n=76 Participants
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
n=16 Participants
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
|
Part 2- A: DTG 50 mg + EPIVIR 300 mg
n=75 Participants
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC
n=75 Participants
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
n=16 Participants
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Heart Rate (HR): Part 1 and 2
Day 4,n=73,75,16,75,75,16
|
7.5 Beats per minute
Standard Deviation 9.28
|
8.9 Beats per minute
Standard Deviation 7.68
|
9.6 Beats per minute
Standard Deviation 9.15
|
8.9 Beats per minute
Standard Deviation 8.31
|
6.1 Beats per minute
Standard Deviation 8.39
|
9.5 Beats per minute
Standard Deviation 10.10
|
|
Change From Baseline in Heart Rate (HR): Part 1 and 2
4 hour,n=75,76,16,75,75,16
|
0.6 Beats per minute
Standard Deviation 5.49
|
0.4 Beats per minute
Standard Deviation 4.25
|
4.9 Beats per minute
Standard Deviation 3.84
|
0.1 Beats per minute
Standard Deviation 5.25
|
-0.3 Beats per minute
Standard Deviation 5.43
|
3.0 Beats per minute
Standard Deviation 3.22
|
|
Change From Baseline in Heart Rate (HR): Part 1 and 2
Day 2,n=74,75,16,75,75,16
|
2.2 Beats per minute
Standard Deviation 5.53
|
1.9 Beats per minute
Standard Deviation 4.60
|
2.9 Beats per minute
Standard Deviation 4.17
|
1.6 Beats per minute
Standard Deviation 5.48
|
0.6 Beats per minute
Standard Deviation 5.74
|
1.6 Beats per minute
Standard Deviation 5.44
|
|
Change From Baseline in Heart Rate (HR): Part 1 and 2
Day 3,n=74,75,16,75,75,16
|
5.1 Beats per minute
Standard Deviation 8.15
|
6.0 Beats per minute
Standard Deviation 6.35
|
5.8 Beats per minute
Standard Deviation 6.80
|
5.3 Beats per minute
Standard Deviation 7.23
|
3.8 Beats per minute
Standard Deviation 7.13
|
7.7 Beats per minute
Standard Deviation 10.42
|
SECONDARY outcome
Timeframe: Up to Week 11Population: Safety Population.
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinaemia were categorized as SAE. Participants having any AE or SAE are presented.
Outcome measures
| Measure |
A: DTG 50 mg + EPIVIR 300 mg
n=75 Participants
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
n=76 Participants
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
n=16 Participants
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
|
Part 2- A: DTG 50 mg + EPIVIR 300 mg
n=75 Participants
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC
n=75 Participants
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
n=16 Participants
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Part 1 and 2
AEs
|
14 Participants
|
18 Participants
|
1 Participants
|
15 Participants
|
12 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Part 1 and 2
SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Part 1- A: DTG 50 mg + EPIVIR 300 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1- B: DTG 50 mg/ 3TC 300 mg Monolayer FDC
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 2- A: DTG 50 mg + EPIVIR 300 mg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part 1- A: DTG 50 mg + EPIVIR 300 mg
n=75 participants at risk
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 1- B: DTG 50 mg/ 3TC 300 mg Monolayer FDC
n=76 participants at risk
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
n=16 participants at risk
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
|
Part 2- A: DTG 50 mg + EPIVIR 300 mg
n=75 participants at risk
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC
n=75 participants at risk
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
|
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
n=16 participants at risk
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
2.7%
2/75 • AEs and SAEs were collected from the start of study treatment until the follow-up contact (Up to 11 weeks)
Safety Population comprised of all participants who were enrolled in the study and received at least one dose of study drug.
|
6.6%
5/76 • AEs and SAEs were collected from the start of study treatment until the follow-up contact (Up to 11 weeks)
Safety Population comprised of all participants who were enrolled in the study and received at least one dose of study drug.
|
6.2%
1/16 • AEs and SAEs were collected from the start of study treatment until the follow-up contact (Up to 11 weeks)
Safety Population comprised of all participants who were enrolled in the study and received at least one dose of study drug.
|
10.7%
8/75 • AEs and SAEs were collected from the start of study treatment until the follow-up contact (Up to 11 weeks)
Safety Population comprised of all participants who were enrolled in the study and received at least one dose of study drug.
|
8.0%
6/75 • AEs and SAEs were collected from the start of study treatment until the follow-up contact (Up to 11 weeks)
Safety Population comprised of all participants who were enrolled in the study and received at least one dose of study drug.
|
0.00%
0/16 • AEs and SAEs were collected from the start of study treatment until the follow-up contact (Up to 11 weeks)
Safety Population comprised of all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/75 • AEs and SAEs were collected from the start of study treatment until the follow-up contact (Up to 11 weeks)
Safety Population comprised of all participants who were enrolled in the study and received at least one dose of study drug.
|
0.00%
0/76 • AEs and SAEs were collected from the start of study treatment until the follow-up contact (Up to 11 weeks)
Safety Population comprised of all participants who were enrolled in the study and received at least one dose of study drug.
|
0.00%
0/16 • AEs and SAEs were collected from the start of study treatment until the follow-up contact (Up to 11 weeks)
Safety Population comprised of all participants who were enrolled in the study and received at least one dose of study drug.
|
0.00%
0/75 • AEs and SAEs were collected from the start of study treatment until the follow-up contact (Up to 11 weeks)
Safety Population comprised of all participants who were enrolled in the study and received at least one dose of study drug.
|
0.00%
0/75 • AEs and SAEs were collected from the start of study treatment until the follow-up contact (Up to 11 weeks)
Safety Population comprised of all participants who were enrolled in the study and received at least one dose of study drug.
|
6.2%
1/16 • AEs and SAEs were collected from the start of study treatment until the follow-up contact (Up to 11 weeks)
Safety Population comprised of all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/75 • AEs and SAEs were collected from the start of study treatment until the follow-up contact (Up to 11 weeks)
Safety Population comprised of all participants who were enrolled in the study and received at least one dose of study drug.
|
0.00%
0/76 • AEs and SAEs were collected from the start of study treatment until the follow-up contact (Up to 11 weeks)
Safety Population comprised of all participants who were enrolled in the study and received at least one dose of study drug.
|
0.00%
0/16 • AEs and SAEs were collected from the start of study treatment until the follow-up contact (Up to 11 weeks)
Safety Population comprised of all participants who were enrolled in the study and received at least one dose of study drug.
|
0.00%
0/75 • AEs and SAEs were collected from the start of study treatment until the follow-up contact (Up to 11 weeks)
Safety Population comprised of all participants who were enrolled in the study and received at least one dose of study drug.
|
0.00%
0/75 • AEs and SAEs were collected from the start of study treatment until the follow-up contact (Up to 11 weeks)
Safety Population comprised of all participants who were enrolled in the study and received at least one dose of study drug.
|
6.2%
1/16 • AEs and SAEs were collected from the start of study treatment until the follow-up contact (Up to 11 weeks)
Safety Population comprised of all participants who were enrolled in the study and received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER