Trial Outcomes & Findings for A Phase IV, Open Label, 4-period Cross-over Study to Investigate a Drug Interaction Between Lamivudine and Sorbitol Oral Solutions in Healthy Volunteers (NCT NCT02634073)
NCT ID: NCT02634073
Last Updated: 2017-05-15
Results Overview
Serial blood sample were collected at Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose in each treatment period. AUC was determined using the trapezoidal rule. Analysis of variance (ANOVA), considering treatment and period as fixed effects and participant as random effect, was performed using Mixed Linear Models procedure to compare the plasma lamivudine Pharmacokinetic (PK) parameters.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
16 participants
Primary outcome timeframe
Day 1 to Day 3 in each treatment period
Results posted on
2017-05-15
Participant Flow
Sixteen subjects were randomized to one of the 4 treatment sequences separated by \>=7 day washout between doses.
Participant milestones
| Measure |
Treatment Sequence 1: ADBC
Participants were randomized to receive a single dose of each of the four treatments where A: Lamivudine 300 mg, B: Lamivudine 300 mg+ Sorbitol 3.2 g, C: Lamivudine 300 mg+ Sorbitol 10.2 g, D: Lamivudine 300 mg+ Sorbitol 13.4 g. All doses were administered after an overnight fast and there was \>=7days washout between each period
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Treatment Sequence 2: BACD
Participants were randomized to receive a single dose of each of the four treatments where A: Lamivudine 300 mg, B: Lamivudine 300 mg+ Sorbitol 3.2 g, C: Lamivudine 300 mg+ Sorbitol 10.2 g, D: Lamivudine 300 mg+ Sorbitol 13.4 g. All doses were administered after an overnight fast and there was \>=7days washout between each period
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Treatment Sequence 3: CBDA
Participants were randomized to receive a single dose of each of the four treatments where A: Lamivudine 300 mg, B: Lamivudine 300 mg+ Sorbitol 3.2 g, C: Lamivudine 300 mg+ Sorbitol 10.2 g, D: Lamivudine 300 mg+ Sorbitol 13.4 g. All doses were administered after an overnight fast and there was \>=7days washout between each period
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Treatment Sequence 4: DCAB
Participants were randomized to receive a single dose of each of the four treatments where A: Lamivudine 300 mg, B: Lamivudine 300 mg+ Sorbitol 3.2 g, C: Lamivudine 300 mg+ Sorbitol 10.2 g, D: Lamivudine 300 mg+ Sorbitol 13.4 g. All doses were administered after an overnight fast and there was \>=7days washout between each period
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|---|---|---|---|---|
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Overall Study
STARTED
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4
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4
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4
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4
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Overall Study
COMPLETED
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4
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4
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4
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4
|
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Overall Study
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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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase IV, Open Label, 4-period Cross-over Study to Investigate a Drug Interaction Between Lamivudine and Sorbitol Oral Solutions in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
All Treatment Groups Combined
n=16 Participants
Sixteen participants were randomized to receive one of the following 4 treatment sequences : Treatment sequence 1 : ABCD; Treatment sequence 2: DABC; Trearment sequence 3: BCDA; Treatment sequence 4: CDAB; where A: Lamivudine 300 mg, B: Lamivudine 300 mg+ Sorbitol 3.2 g, C: Lamivudine 300 mg+ Sorbitol 10.2 g, D: Lamivudine 300 mg+ Sorbitol 13.4 g.
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|---|---|
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Age, Continuous
|
40.6 Years
STANDARD_DEVIATION 12.30 • n=5 Participants
|
|
Sex: Female, Male
Female
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2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
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14 Participants
n=5 Participants
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|
Race/Ethnicity, Customized
African American/African Heritage
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6 Participants
n=5 Participants
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Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
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10 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Day 1 to Day 3 in each treatment periodPopulation: PK Summary Population: defined as participants who had valid lamivudine PK parameter estimates from both reference and test treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Serial blood sample were collected at Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose in each treatment period. AUC was determined using the trapezoidal rule. Analysis of variance (ANOVA), considering treatment and period as fixed effects and participant as random effect, was performed using Mixed Linear Models procedure to compare the plasma lamivudine Pharmacokinetic (PK) parameters.
Outcome measures
| Measure |
A: Lamivudine 300 mg
n=16 Participants
After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
B: Lamivudine 300 mg + Sorbitol 3.2 g
n=16 Participants
After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
C: Lamivudine 300 mg + Sorbitol 10.2 g
n=16 Participants
After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
D: Lamivudine 300 mg + Sorbitol 13.4 g
n=16 Participants
After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
|---|---|---|---|---|
|
Plasma Lamivudine Area Under the Plasma Concentration Time Curve (AUC) From Time Zero to the Last Quantifiable Time Point (AUC[0-t]), AUC From Time Zero Extrapolated to Infinity (AUC[0-inf]) and AUC From Time Zero to 24 Hours (AUC[0-24])
AUC (0-inf); n=16, 14, 16, 13
|
13.2 hour (h)*microgram (mcg)/milliliter (mL)
Geometric Coefficient of Variation 22.3
|
11.3 hour (h)*microgram (mcg)/milliliter (mL)
Geometric Coefficient of Variation 21.2
|
8.93 hour (h)*microgram (mcg)/milliliter (mL)
Geometric Coefficient of Variation 22.1
|
8.60 hour (h)*microgram (mcg)/milliliter (mL)
Geometric Coefficient of Variation 24.1
|
|
Plasma Lamivudine Area Under the Plasma Concentration Time Curve (AUC) From Time Zero to the Last Quantifiable Time Point (AUC[0-t]), AUC From Time Zero Extrapolated to Infinity (AUC[0-inf]) and AUC From Time Zero to 24 Hours (AUC[0-24])
AUC (0-t) ; n=16, 16, 16, 16
|
12.9 hour (h)*microgram (mcg)/milliliter (mL)
Geometric Coefficient of Variation 23.0
|
10.6 hour (h)*microgram (mcg)/milliliter (mL)
Geometric Coefficient of Variation 21.6
|
8.21 hour (h)*microgram (mcg)/milliliter (mL)
Geometric Coefficient of Variation 22.9
|
7.55 hour (h)*microgram (mcg)/milliliter (mL)
Geometric Coefficient of Variation 26.8
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|
Plasma Lamivudine Area Under the Plasma Concentration Time Curve (AUC) From Time Zero to the Last Quantifiable Time Point (AUC[0-t]), AUC From Time Zero Extrapolated to Infinity (AUC[0-inf]) and AUC From Time Zero to 24 Hours (AUC[0-24])
AUC (0-24) ; n=16, 16, 16, 16
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12.4 hour (h)*microgram (mcg)/milliliter (mL)
Geometric Coefficient of Variation 23.6
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9.96 hour (h)*microgram (mcg)/milliliter (mL)
Geometric Coefficient of Variation 22.6
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7.54 hour (h)*microgram (mcg)/milliliter (mL)
Geometric Coefficient of Variation 23.7
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6.91 hour (h)*microgram (mcg)/milliliter (mL)
Geometric Coefficient of Variation 28.9
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PRIMARY outcome
Timeframe: Day 1 to Day 3 in each treatment periodSerial blood sample were collected at Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose in each treatment period. Time of the last measurable concentration (t) was 48 hours for all participants and all treatments. ANOVA, considering treatment and period as fixed effects and participant as random effect, was performed using Mixed Linear Models procedure to compare the plasma lamivudine PK parameters.
Outcome measures
| Measure |
A: Lamivudine 300 mg
n=16 Participants
After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
B: Lamivudine 300 mg + Sorbitol 3.2 g
n=16 Participants
After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
C: Lamivudine 300 mg + Sorbitol 10.2 g
n=16 Participants
After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
D: Lamivudine 300 mg + Sorbitol 13.4 g
n=16 Participants
After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
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|---|---|---|---|---|
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Plasma Lamivudine Maximum Observed Concentration (Cmax), Concentration at 24 Hour (h) Post-dose (C24) and Last Measurable Concentration (Ct)
C24
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0.036 mcg/mL
Geometric Coefficient of Variation 25.1
|
0.036 mcg/mL
Geometric Coefficient of Variation 31.1
|
0.041 mcg/mL
Geometric Coefficient of Variation 21.8
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0.039 mcg/mL
Geometric Coefficient of Variation 21.6
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Plasma Lamivudine Maximum Observed Concentration (Cmax), Concentration at 24 Hour (h) Post-dose (C24) and Last Measurable Concentration (Ct)
Ct
|
0.013 mcg/mL
Geometric Coefficient of Variation 28.4
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0.017 mcg/mL
Geometric Coefficient of Variation 26.3
|
0.019 mcg/mL
Geometric Coefficient of Variation 38.7
|
0.018 mcg/mL
Geometric Coefficient of Variation 51.5
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Plasma Lamivudine Maximum Observed Concentration (Cmax), Concentration at 24 Hour (h) Post-dose (C24) and Last Measurable Concentration (Ct)
Cmax
|
3.34 mcg/mL
Geometric Coefficient of Variation 34.9
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2.42 mcg/mL
Geometric Coefficient of Variation 32.7
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1.60 mcg/mL
Geometric Coefficient of Variation 27.2
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1.52 mcg/mL
Geometric Coefficient of Variation 30.9
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PRIMARY outcome
Timeframe: Day 1 to Day 3 in each treatment periodPopulation: PK Summary Population
Serial blood sample were collected at Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose in each treatment period. ANOVA, considering treatment and period as fixed effects and participant as random effect, was performed using Mixed Linear Models procedure to compare the plasma lamivudine t1/2.
Outcome measures
| Measure |
A: Lamivudine 300 mg
n=16 Participants
After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
B: Lamivudine 300 mg + Sorbitol 3.2 g
n=14 Participants
After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
C: Lamivudine 300 mg + Sorbitol 10.2 g
n=16 Participants
After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
D: Lamivudine 300 mg + Sorbitol 13.4 g
n=13 Participants
After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
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|---|---|---|---|---|
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Lamivudine Elimination Half-life in Plasma (t1/2)
|
13.9 Hour (Hr)
Geometric Coefficient of Variation 20.9
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19.0 Hour (Hr)
Geometric Coefficient of Variation 40.6
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21.2 Hour (Hr)
Geometric Coefficient of Variation 47.3
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17.3 Hour (Hr)
Geometric Coefficient of Variation 48.6
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PRIMARY outcome
Timeframe: Day 1 to Day 3 in each treatment periodPopulation: PK Summary Population
Serial blood sample were collected at Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose in each treatment period. ANOVA, considering treatment and period as fixed effects and participant as random effect, was performed using Mixed Linear Models procedure to compare the plasma lamivudine CL/F
Outcome measures
| Measure |
A: Lamivudine 300 mg
n=16 Participants
After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
B: Lamivudine 300 mg + Sorbitol 3.2 g
n=14 Participants
After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
C: Lamivudine 300 mg + Sorbitol 10.2 g
n=16 Participants
After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
D: Lamivudine 300 mg + Sorbitol 13.4 g
n=13 Participants
After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
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|---|---|---|---|---|
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Plasma Lamivudine Apparent Oral Clearance (CL/F)
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22.738 Liter (L)/hr
Geometric Coefficient of Variation 22.3
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26.621 Liter (L)/hr
Geometric Coefficient of Variation 21.2
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33.608 Liter (L)/hr
Geometric Coefficient of Variation 22.1
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34.875 Liter (L)/hr
Geometric Coefficient of Variation 24.1
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PRIMARY outcome
Timeframe: Day 1 to Day 3 in each treatment periodSerial blood sample were collected at Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose in each treatment period.
Outcome measures
| Measure |
A: Lamivudine 300 mg
n=16 Participants
After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
B: Lamivudine 300 mg + Sorbitol 3.2 g
n=16 Participants
After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
C: Lamivudine 300 mg + Sorbitol 10.2 g
n=16 Participants
After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
D: Lamivudine 300 mg + Sorbitol 13.4 g
n=16 Participants
After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
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|---|---|---|---|---|
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Time to Observed Maximum Lamivudine Plasma Concentration (Tmax), Time of Last Measurable Plasma Concentration (Tlast) and Absorption Lag Time in Plasma (Tlag)
tmax
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0.75 Hr
Interval 0.5 to 1.5
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1.000 Hr
Interval 0.5 to 1.5
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1.00 Hr
Interval 0.5 to 2.5
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1.26 Hr
Interval 0.5 to 3.0
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Time to Observed Maximum Lamivudine Plasma Concentration (Tmax), Time of Last Measurable Plasma Concentration (Tlast) and Absorption Lag Time in Plasma (Tlag)
tlast
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48.00 Hr
Interval 48.0 to 48.22
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48.00 Hr
Interval 47.5 to 48.08
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48.00 Hr
Interval 47.57 to 48.03
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48.00 Hr
Interval 48.0 to 48.07
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Time to Observed Maximum Lamivudine Plasma Concentration (Tmax), Time of Last Measurable Plasma Concentration (Tlast) and Absorption Lag Time in Plasma (Tlag)
tlag
|
0.000 Hr
Interval 0.0 to 0.0
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0.000 Hr
Interval 0.0 to 0.0
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0.000 Hr
Interval 0.0 to 0.0
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0.000 Hr
Interval 0.0 to 0.0
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SECONDARY outcome
Timeframe: Up to 5 WeeksPopulation: Safety Population: defined as all participants who enrolled into the study and received at least one dose of study drug.
An AE is any untoward medical occurrence, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect or event that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition.
Outcome measures
| Measure |
A: Lamivudine 300 mg
n=16 Participants
After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
B: Lamivudine 300 mg + Sorbitol 3.2 g
n=16 Participants
After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
C: Lamivudine 300 mg + Sorbitol 10.2 g
n=16 Participants
After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
D: Lamivudine 300 mg + Sorbitol 13.4 g
n=16 Participants
After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
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|---|---|---|---|---|
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Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAE)
AEs
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1 Participants
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2 Participants
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1 Participants
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1 Participants
|
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Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAE)
SAEs
|
0 Participants
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0 Participants
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0 Participants
|
0 Participants
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SECONDARY outcome
Timeframe: Baseline and up to 5 weeksPopulation: Safety Population.Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Change from Baseline for pulse rate was calculated as the post-dose visit value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/period.
Outcome measures
| Measure |
A: Lamivudine 300 mg
n=16 Participants
After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
B: Lamivudine 300 mg + Sorbitol 3.2 g
n=16 Participants
After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
C: Lamivudine 300 mg + Sorbitol 10.2 g
n=16 Participants
After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
D: Lamivudine 300 mg + Sorbitol 13.4 g
n=16 Participants
After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
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|---|---|---|---|---|
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Change From Baseline in Pulse Rate
Day 3; n=15, 16, 16, 16
|
6.5 Beats/min
Standard Deviation 3.42
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3.9 Beats/min
Standard Deviation 14.3
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6.0 Beats/min
Standard Deviation 6.86
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7.4 Beats/min
Standard Deviation 8.57
|
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Change From Baseline in Pulse Rate
Follow up; n=16, 16, 16, 16
|
5.8 Beats/min
Standard Deviation 6.41
|
5.8 Beats/min
Standard Deviation 6.41
|
5.8 Beats/min
Standard Deviation 6.41
|
5.8 Beats/min
Standard Deviation 6.41
|
SECONDARY outcome
Timeframe: Baseline and up to 5 weeksPopulation: Safety Population
Change from Baseline for body temperature was calculated as the post-dose visit value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/period.
Outcome measures
| Measure |
A: Lamivudine 300 mg
n=16 Participants
After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
B: Lamivudine 300 mg + Sorbitol 3.2 g
n=16 Participants
After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
C: Lamivudine 300 mg + Sorbitol 10.2 g
n=16 Participants
After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
D: Lamivudine 300 mg + Sorbitol 13.4 g
n=16 Participants
After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
|---|---|---|---|---|
|
Change From Baseline in Body Temperature
Day 3
|
0.03 Degree centigrade
Standard Deviation 0.252
|
0.07 Degree centigrade
Standard Deviation 0.189
|
0.08 Degree centigrade
Standard Deviation 0.183
|
-0.03 Degree centigrade
Standard Deviation 0.145
|
|
Change From Baseline in Body Temperature
Follow up
|
-0.01 Degree centigrade
Standard Deviation 0.365
|
-0.01 Degree centigrade
Standard Deviation 0.365
|
-0.01 Degree centigrade
Standard Deviation 0.365
|
-0.01 Degree centigrade
Standard Deviation 0.365
|
SECONDARY outcome
Timeframe: Baseline and up to 5 weeksPopulation: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Change from Baseline for DBP and SBP was calculated as the post-dose visit value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/period.
Outcome measures
| Measure |
A: Lamivudine 300 mg
n=16 Participants
After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
B: Lamivudine 300 mg + Sorbitol 3.2 g
n=16 Participants
After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
C: Lamivudine 300 mg + Sorbitol 10.2 g
n=16 Participants
After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
D: Lamivudine 300 mg + Sorbitol 13.4 g
n=16 Participants
After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
|---|---|---|---|---|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, Day 3; n=15, 16, 16, 16
|
5.1 millimeter of mercury (mmHg)
Standard Deviation 6.41
|
4.5 millimeter of mercury (mmHg)
Standard Deviation 4.13
|
2.1 millimeter of mercury (mmHg)
Standard Deviation 7.46
|
5.6 millimeter of mercury (mmHg)
Standard Deviation 4.87
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, Day 3; n=15, 16, 16, 16
|
3.6 millimeter of mercury (mmHg)
Standard Deviation 9.84
|
3.1 millimeter of mercury (mmHg)
Standard Deviation 8.01
|
5.1 millimeter of mercury (mmHg)
Standard Deviation 7.19
|
5.3 millimeter of mercury (mmHg)
Standard Deviation 7.38
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, Follow up; n=16, 16, 16, 16
|
7.4 millimeter of mercury (mmHg)
Standard Deviation 7.78
|
7.4 millimeter of mercury (mmHg)
Standard Deviation 7.78
|
7.4 millimeter of mercury (mmHg)
Standard Deviation 7.78
|
7.4 millimeter of mercury (mmHg)
Standard Deviation 7.78
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, Follow up; n=16, 16, 16, 16
|
4.6 millimeter of mercury (mmHg)
Standard Deviation 6.54
|
4.6 millimeter of mercury (mmHg)
Standard Deviation 6.54
|
4.6 millimeter of mercury (mmHg)
Standard Deviation 6.54
|
4.6 millimeter of mercury (mmHg)
Standard Deviation 6.54
|
SECONDARY outcome
Timeframe: Up to Week 5Population: Safety Population
Division of Acquired immune deficiency syndrome (DAIDS) Table AE grades 1, 2, 3, and 4 of laboratory abnormalities were applied and grade were summarized by treatment and day and were listed by participant, treatment, day, and actual date and time. Treatment emergent grades are defined as any new toxicity grades or the worsened grades compared to Baseline grade. Treatment emergent lab abnormality Grade 1 for aspartate aminotransferase and sodium at follow-up visit are summarized.
Outcome measures
| Measure |
A: Lamivudine 300 mg
n=16 Participants
After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
B: Lamivudine 300 mg + Sorbitol 3.2 g
n=16 Participants
After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
C: Lamivudine 300 mg + Sorbitol 10.2 g
n=16 Participants
After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
D: Lamivudine 300 mg + Sorbitol 13.4 g
n=16 Participants
After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Laboratory Abnormality Grade
Aspartate Aminotransferase
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Treatment Emergent Laboratory Abnormality Grade
Sodium
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline and up to 5 weeksPopulation: Safety Population
Blood samples were collected at Day -1, Day 3 of every treatment period and at follow-up. Change from Baseline for erythrocytes was calculated as the post-dose visit value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/Period. Day -1 presented the Baseline absolute values; Day 3 and Follow-Up presented the changes from Baseline.
Outcome measures
| Measure |
A: Lamivudine 300 mg
n=16 Participants
After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
B: Lamivudine 300 mg + Sorbitol 3.2 g
n=16 Participants
After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
C: Lamivudine 300 mg + Sorbitol 10.2 g
n=16 Participants
After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
D: Lamivudine 300 mg + Sorbitol 13.4 g
n=16 Participants
After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
|---|---|---|---|---|
|
Change From Baseline in Erythrocytes
Day 3
|
0.351 10^12 cells/L
Standard Deviation 0.298
|
0.389 10^12 cells/L
Standard Deviation 0.200
|
0.339 10^12 cells/L
Standard Deviation 0.257
|
0.380 10^12 cells/L
Standard Deviation 0.243
|
|
Change From Baseline in Erythrocytes
Follow up
|
0.142 10^12 cells/L
Standard Deviation 0.148
|
0.142 10^12 cells/L
Standard Deviation 0.148
|
0.142 10^12 cells/L
Standard Deviation 0.148
|
0.142 10^12 cells/L
Standard Deviation 0.148
|
SECONDARY outcome
Timeframe: Baseline and up to 5 weeksPopulation: Safety Population
Blood samples were collected at Day -1, Day 3 of every treatment period and at follow-up. Change from Baseline for hematocrit was calculated as the post-dose visit value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/period. Day -1 presented the Baseline absolute values; Day 3 and Follow-Up presented the changes from Baseline.
Outcome measures
| Measure |
A: Lamivudine 300 mg
n=16 Participants
After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
B: Lamivudine 300 mg + Sorbitol 3.2 g
n=16 Participants
After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
C: Lamivudine 300 mg + Sorbitol 10.2 g
n=16 Participants
After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
D: Lamivudine 300 mg + Sorbitol 13.4 g
n=16 Participants
After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
|---|---|---|---|---|
|
Change From Baseline in Hematocrit
Day 3
|
0.0338 Fraction of 1
Standard Deviation 0.02429
|
0.0378 Fraction of 1
Standard Deviation 0.02206
|
0.0308 Fraction of 1
Standard Deviation 0.01993
|
0.0353 Fraction of 1
Standard Deviation 0.01892
|
|
Change From Baseline in Hematocrit
Follow up
|
0.0091 Fraction of 1
Standard Deviation 0.01254
|
0.0091 Fraction of 1
Standard Deviation 0.01254
|
0.0091 Fraction of 1
Standard Deviation 0.01254
|
0.0091 Fraction of 1
Standard Deviation 0.01254
|
SECONDARY outcome
Timeframe: Baseline and up to 5 weeksPopulation: Safety Population
Blood samples were collected at Day -1, Day 3 of every treatment period and at follow-up. Change from Baseline for hemoglobin was calculated as the post-dose visit value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/period. Day -1 presented the Baseline absolute values; Day 3 and Follow-Up presented the changes from Baseline.
Outcome measures
| Measure |
A: Lamivudine 300 mg
n=16 Participants
After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
B: Lamivudine 300 mg + Sorbitol 3.2 g
n=16 Participants
After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
C: Lamivudine 300 mg + Sorbitol 10.2 g
n=16 Participants
After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
D: Lamivudine 300 mg + Sorbitol 13.4 g
n=16 Participants
After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
|---|---|---|---|---|
|
Change From Baseline in Hemoglobin
Day 3
|
10.1 G/L
Standard Deviation 8.05
|
10.9 G/L
Standard Deviation 5.26
|
9.8 G/L
Standard Deviation 6.44
|
9.9 G/L
Standard Deviation 5.83
|
|
Change From Baseline in Hemoglobin
Follow up
|
3.4 G/L
Standard Deviation 4.57
|
3.4 G/L
Standard Deviation 4.57
|
3.4 G/L
Standard Deviation 4.57
|
3.4 G/L
Standard Deviation 4.57
|
SECONDARY outcome
Timeframe: Baseline and up to 5 weeksPopulation: Safety Population
Blood samples were collected at Day -1, Day 3 of every treatment period and at follow-up. Change from Baseline for MCH was calculated as the post-dose visit value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/period. Day -1 presented the Baseline absolute values; Day 3 and Follow-Up presented the changes from Baseline.
Outcome measures
| Measure |
A: Lamivudine 300 mg
n=16 Participants
After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
B: Lamivudine 300 mg + Sorbitol 3.2 g
n=16 Participants
After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
C: Lamivudine 300 mg + Sorbitol 10.2 g
n=16 Participants
After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
D: Lamivudine 300 mg + Sorbitol 13.4 g
n=16 Participants
After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
|---|---|---|---|---|
|
Change From Baseline in Mean Corpuscular Hemoglobin (MCH)
Day 3
|
0.02 Picogram
Standard Deviation 0.500
|
-0.03 Picogram
Standard Deviation 0.419
|
0.06 Picogram
Standard Deviation 0.403
|
-0.24 Picogram
Standard Deviation 0.622
|
|
Change From Baseline in Mean Corpuscular Hemoglobin (MCH)
Follow up
|
-0.14 Picogram
Standard Deviation 0.567
|
-0.14 Picogram
Standard Deviation 0.567
|
-0.14 Picogram
Standard Deviation 0.567
|
-0.14 Picogram
Standard Deviation 0.567
|
SECONDARY outcome
Timeframe: Baseline and up to 5 weeksPopulation: Safety Population
Blood samples were collected at Day -1, Day 3 of every treatment period and at follow-up. Change from Baseline for MCV was calculated as the post-dose visit value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/period. Day -1 presented the Baseline absolute values; Day 3 and Follow-Up presented the changes from Baseline.
Outcome measures
| Measure |
A: Lamivudine 300 mg
n=16 Participants
After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
B: Lamivudine 300 mg + Sorbitol 3.2 g
n=16 Participants
After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
C: Lamivudine 300 mg + Sorbitol 10.2 g
n=16 Participants
After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
D: Lamivudine 300 mg + Sorbitol 13.4 g
n=16 Participants
After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
|---|---|---|---|---|
|
Change From Baseline in Mean Corpuscular Volume (MCV)
Day 3
|
0.71 Femtoliter
Standard Deviation 1.95
|
0.63 Femtoliter
Standard Deviation 1.89
|
0.35 Femtoliter
Standard Deviation 2.06
|
0.44 Femtoliter
Standard Deviation 1.54
|
|
Change From Baseline in Mean Corpuscular Volume (MCV)
Follow up
|
-0.77 Femtoliter
Standard Deviation 1.55
|
-0.77 Femtoliter
Standard Deviation 1.55
|
-0.77 Femtoliter
Standard Deviation 1.55
|
-0.77 Femtoliter
Standard Deviation 1.55
|
SECONDARY outcome
Timeframe: Baseline and up to 5 weeksPopulation: Safety Population
Blood samples were collected at Day -1, Day 3 of every treatment period and at follow-up. Change from Baseline for platelets, neutrophils, lymphocytes, monocytes, eosinophils, basophils were calculated as the post-dose visit value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/period. Day -1 presented the Baseline absolute values; Day 3 and Follow-Up presented the changes from Baseline.
Outcome measures
| Measure |
A: Lamivudine 300 mg
n=16 Participants
After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
B: Lamivudine 300 mg + Sorbitol 3.2 g
n=16 Participants
After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
C: Lamivudine 300 mg + Sorbitol 10.2 g
n=16 Participants
After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
D: Lamivudine 300 mg + Sorbitol 13.4 g
n=16 Participants
After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
|---|---|---|---|---|
|
Change From Baseline in Platelets, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils
Neutrophils, Day 3
|
0.35 10^9 cells/L
Standard Deviation 0.612
|
0.42 10^9 cells/L
Standard Deviation 0.733
|
0.53 10^9 cells/L
Standard Deviation 0.603
|
0.31 10^9 cells/L
Standard Deviation 0.979
|
|
Change From Baseline in Platelets, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils
Lymphocytes, Follow up
|
-0.08 10^9 cells/L
Standard Deviation 0.371
|
-0.08 10^9 cells/L
Standard Deviation 0.371
|
-0.08 10^9 cells/L
Standard Deviation 0.371
|
-0.08 10^9 cells/L
Standard Deviation 0.371
|
|
Change From Baseline in Platelets, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils
Monocytes, Follow up
|
-0.08 10^9 cells/L
Standard Deviation 0.134
|
-0.08 10^9 cells/L
Standard Deviation 0.134
|
-0.08 10^9 cells/L
Standard Deviation 0.134
|
-0.08 10^9 cells/L
Standard Deviation 0.134
|
|
Change From Baseline in Platelets, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils
Eosinophils, Day 3
|
-0.03 10^9 cells/L
Standard Deviation 0.070
|
-0.02 10^9 cells/L
Standard Deviation 0.075
|
-0.04 10^9 cells/L
Standard Deviation 0.062
|
-0.03 10^9 cells/L
Standard Deviation 0.070
|
|
Change From Baseline in Platelets, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils
Basophils, Day 3
|
-0.01 10^9 cells/L
Standard Deviation 0.025
|
0.00 10^9 cells/L
Standard Deviation 0.000
|
-0.01 10^9 cells/L
Standard Deviation 0.025
|
0.00 10^9 cells/L
Standard Deviation 0.037
|
|
Change From Baseline in Platelets, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils
Basophils, Follow up
|
-0.01 10^9 cells/L
Standard Deviation 0.025
|
-0.01 10^9 cells/L
Standard Deviation 0.025
|
-0.01 10^9 cells/L
Standard Deviation 0.025
|
-0.01 10^9 cells/L
Standard Deviation 0.025
|
|
Change From Baseline in Platelets, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils
Platelets, Day 3
|
19.2 10^9 cells/L
Standard Deviation 20.69
|
13.9 10^9 cells/L
Standard Deviation 15.75
|
13.8 10^9 cells/L
Standard Deviation 20.92
|
6.1 10^9 cells/L
Standard Deviation 24.65
|
|
Change From Baseline in Platelets, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils
Platelets, Follow up
|
2.3 10^9 cells/L
Standard Deviation 19.36
|
2.3 10^9 cells/L
Standard Deviation 19.36
|
2.3 10^9 cells/L
Standard Deviation 19.36
|
2.3 10^9 cells/L
Standard Deviation 19.36
|
|
Change From Baseline in Platelets, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils
Neutrophils, Follow up
|
-0.12 10^9 cells/L
Standard Deviation 0.717
|
-0.12 10^9 cells/L
Standard Deviation 0.717
|
-0.12 10^9 cells/L
Standard Deviation 0.717
|
-0.12 10^9 cells/L
Standard Deviation 0.717
|
|
Change From Baseline in Platelets, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils
Lymphocytes, Day 3
|
0.10 10^9 cells/L
Standard Deviation 0.432
|
0.17 10^9 cells/L
Standard Deviation 0.338
|
0.00 10^9 cells/L
Standard Deviation 0.446
|
-0.03 10^9 cells/L
Standard Deviation 0.466
|
|
Change From Baseline in Platelets, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils
Monocytes, Day 3
|
0.01 10^9 cells/L
Standard Deviation 0.085
|
0.03 10^9 cells/L
Standard Deviation 0.060
|
-0.02 10^9 cells/L
Standard Deviation 0.122
|
-0.01 10^9 cells/L
Standard Deviation 0.112
|
|
Change From Baseline in Platelets, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils
Eosinophils, Follow up
|
-0.01 10^9 cells/L
Standard Deviation 0.068
|
-0.01 10^9 cells/L
Standard Deviation 0.068
|
-0.01 10^9 cells/L
Standard Deviation 0.068
|
-0.01 10^9 cells/L
Standard Deviation 0.068
|
SECONDARY outcome
Timeframe: Baseline and up to 5 weeksPopulation: Safety Population
Blood samples were collected at Day -1, Day 3 of every treatment period and at follow-up. Change from Baseline for BUN, sodium, potassium, glucose, calcium were calculated as the post-dose visit value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/period. Day -1 presented the Baseline absolute values; Day 3 and Follow-Up presented the changes from Baseline.
Outcome measures
| Measure |
A: Lamivudine 300 mg
n=16 Participants
After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
B: Lamivudine 300 mg + Sorbitol 3.2 g
n=16 Participants
After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
C: Lamivudine 300 mg + Sorbitol 10.2 g
n=16 Participants
After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
D: Lamivudine 300 mg + Sorbitol 13.4 g
n=16 Participants
After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
|---|---|---|---|---|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Sodium, Potassium, Glucose, Calcium
Glucose, Day 3
|
-0.05897 millimole (mmol)/L
Standard Deviation 0.496601
|
0.05550 millimole (mmol)/L
Standard Deviation 0.342125
|
0.01388 millimole (mmol)/L
Standard Deviation 0.342425
|
-0.03122 millimole (mmol)/L
Standard Deviation 0.657300
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Sodium, Potassium, Glucose, Calcium
BUN, Day 3
|
-0.0892 millimole (mmol)/L
Standard Deviation 1.08675
|
-0.5578 millimole (mmol)/L
Standard Deviation 0.93974
|
0.0223 millimole (mmol)/L
Standard Deviation 1.05476
|
0.0446 millimole (mmol)/L
Standard Deviation 1.38496
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Sodium, Potassium, Glucose, Calcium
BUN, Follow up
|
-0.4909 millimole (mmol)/L
Standard Deviation 1.00870
|
-0.4909 millimole (mmol)/L
Standard Deviation 1.00870
|
-0.4909 millimole (mmol)/L
Standard Deviation 1.00870
|
-0.4909 millimole (mmol)/L
Standard Deviation 1.00870
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Sodium, Potassium, Glucose, Calcium
Sodium, Day 3
|
-2.4 millimole (mmol)/L
Standard Deviation 1.71
|
-1.2 millimole (mmol)/L
Standard Deviation 1.42
|
-2.6 millimole (mmol)/L
Standard Deviation 1.59
|
-2.0 millimole (mmol)/L
Standard Deviation 1.63
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Sodium, Potassium, Glucose, Calcium
Sodium, Follow up
|
-0.1 millimole (mmol)/L
Standard Deviation 2.03
|
-0.1 millimole (mmol)/L
Standard Deviation 2.03
|
-0.1 millimole (mmol)/L
Standard Deviation 2.03
|
-0.1 millimole (mmol)/L
Standard Deviation 2.03
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Sodium, Potassium, Glucose, Calcium
Potassium, Day 3
|
0.06 millimole (mmol)/L
Standard Deviation 0.418
|
0.09 millimole (mmol)/L
Standard Deviation 0.481
|
0.19 millimole (mmol)/L
Standard Deviation 0.382
|
0.06 millimole (mmol)/L
Standard Deviation 0.386
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Sodium, Potassium, Glucose, Calcium
Potassium, Follow up
|
0.02 millimole (mmol)/L
Standard Deviation 0.387
|
0.02 millimole (mmol)/L
Standard Deviation 0.387
|
0.02 millimole (mmol)/L
Standard Deviation 0.387
|
0.02 millimole (mmol)/L
Standard Deviation 0.387
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Sodium, Potassium, Glucose, Calcium
Glucose, Follow up
|
0.33994 millimole (mmol)/L
Standard Deviation 0.546377
|
0.33994 millimole (mmol)/L
Standard Deviation 0.546377
|
0.33994 millimole (mmol)/L
Standard Deviation 0.546377
|
0.33994 millimole (mmol)/L
Standard Deviation 0.546377
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Sodium, Potassium, Glucose, Calcium
Calcium Day 3
|
0.0906 millimole (mmol)/L
Standard Deviation 0.11614
|
0.1141 millimole (mmol)/L
Standard Deviation 0.08214
|
0.1141 millimole (mmol)/L
Standard Deviation 0.07744
|
0.0875 millimole (mmol)/L
Standard Deviation 0.07583
|
|
Change From Baseline in Blood Urea Nitrogen (BUN), Sodium, Potassium, Glucose, Calcium
Calcium, Follow up
|
0.0328 millimole (mmol)/L
Standard Deviation 0.05379
|
0.0328 millimole (mmol)/L
Standard Deviation 0.05379
|
0.0328 millimole (mmol)/L
Standard Deviation 0.05379
|
0.0328 millimole (mmol)/L
Standard Deviation 0.05379
|
SECONDARY outcome
Timeframe: Baseline and up to 5 weeksPopulation: Safety Population
Blood samples were collected at Day -1, Day 3 of every treatment period and at follow-up. Change from Baseline for AST, ALT and alkaline phosphatase were calculated as the post-dose visit value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/period. Day -1 presented the Baseline absolute values; Day 3 and Follow-Up presented the changes from Baseline.
Outcome measures
| Measure |
A: Lamivudine 300 mg
n=16 Participants
After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
B: Lamivudine 300 mg + Sorbitol 3.2 g
n=16 Participants
After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
C: Lamivudine 300 mg + Sorbitol 10.2 g
n=16 Participants
After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
D: Lamivudine 300 mg + Sorbitol 13.4 g
n=16 Participants
After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
|---|---|---|---|---|
|
Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphates
AST, Day 3
|
-3.1 Unit (U)/L
Standard Deviation 4.84
|
-3.5 Unit (U)/L
Standard Deviation 3.67
|
-2.3 Unit (U)/L
Standard Deviation 2.44
|
-19.1 Unit (U)/L
Standard Deviation 68.13
|
|
Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphates
AST, Follow up
|
1.1 Unit (U)/L
Standard Deviation 15.86
|
1.1 Unit (U)/L
Standard Deviation 15.86
|
1.1 Unit (U)/L
Standard Deviation 15.86
|
1.1 Unit (U)/L
Standard Deviation 15.86
|
|
Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphates
ALT, Day 3
|
-2.2 Unit (U)/L
Standard Deviation 5.78
|
-2.7 Unit (U)/L
Standard Deviation 4.16
|
-2.2 Unit (U)/L
Standard Deviation 2.59
|
-2.5 Unit (U)/L
Standard Deviation 7.05
|
|
Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphates
ALT, Follow up
|
0.4 Unit (U)/L
Standard Deviation 8.97
|
0.4 Unit (U)/L
Standard Deviation 8.97
|
0.4 Unit (U)/L
Standard Deviation 8.97
|
0.4 Unit (U)/L
Standard Deviation 8.97
|
|
Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphates
Alkaline phosphatatse, Day 3
|
-0.4 Unit (U)/L
Standard Deviation 7.96
|
1.1 Unit (U)/L
Standard Deviation 6.24
|
1.5 Unit (U)/L
Standard Deviation 8.45
|
-0.2 Unit (U)/L
Standard Deviation 7.37
|
|
Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphates
Alkaline phosphatase, Follow up
|
1.2 Unit (U)/L
Standard Deviation 7.01
|
1.2 Unit (U)/L
Standard Deviation 7.01
|
1.2 Unit (U)/L
Standard Deviation 7.01
|
1.2 Unit (U)/L
Standard Deviation 7.01
|
SECONDARY outcome
Timeframe: Baseline and up to 5 weeksPopulation: Safety Population
Blood samples were collected at Day -1, Day 3 of every treatment period and at follow-up. Change from Baseline for creatinine and direct bilirubin were calculated as the post-dose visit value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/period. Change from Baseline in total bilirubine was not assessed. Day -1 presented the Baseline absolute values; Day 3 and Follow-Up presented the changes from Baseline.
Outcome measures
| Measure |
A: Lamivudine 300 mg
n=16 Participants
After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
B: Lamivudine 300 mg + Sorbitol 3.2 g
n=16 Participants
After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
C: Lamivudine 300 mg + Sorbitol 10.2 g
n=16 Participants
After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
D: Lamivudine 300 mg + Sorbitol 13.4 g
n=16 Participants
After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
|---|---|---|---|---|
|
Change From Baseline in Creatinine, Total Bilirubin and Direct Bilirubin
Creatinine, Day 3
|
3.86759 micromole (umol)/L
Standard Deviation 9.112270
|
2.21005 micromole (umol)/L
Standard Deviation 6.847589
|
4.42010 micromole (umol)/L
Standard Deviation 7.217993
|
0.55251 micromole (umol)/L
Standard Deviation 6.011986
|
|
Change From Baseline in Creatinine, Total Bilirubin and Direct Bilirubin
Creatinine, Follow up
|
0.00000 micromole (umol)/L
Standard Deviation 7.217993
|
0.00000 micromole (umol)/L
Standard Deviation 7.217993
|
0.00000 micromole (umol)/L
Standard Deviation 7.217993
|
0.00000 micromole (umol)/L
Standard Deviation 7.217993
|
|
Change From Baseline in Creatinine, Total Bilirubin and Direct Bilirubin
Direct bilirubin, Day 3
|
0.641 micromole (umol)/L
Standard Deviation 0.8550
|
0.107 micromole (umol)/L
Standard Deviation 1.3200
|
0.107 micromole (umol)/L
Standard Deviation 0.7567
|
0.321 micromole (umol)/L
Standard Deviation 1.1202
|
|
Change From Baseline in Creatinine, Total Bilirubin and Direct Bilirubin
Direct bilirubin, Follow up
|
0.107 micromole (umol)/L
Standard Deviation 1.4602
|
0.107 micromole (umol)/L
Standard Deviation 1.4602
|
0.107 micromole (umol)/L
Standard Deviation 1.4602
|
0.107 micromole (umol)/L
Standard Deviation 1.4602
|
SECONDARY outcome
Timeframe: Baseline and up to 5 weeksPopulation: Safety Population
Blood samples were collected at Day -1, Day 3 of every treatment period and at follow-up. Change from Baseline for albumin was calculated as the post-dose Visit Value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/Period. Day -1 presented the Baseline absolute values; Day 3 and Follow-Up presented the changes from Baseline.
Outcome measures
| Measure |
A: Lamivudine 300 mg
n=16 Participants
After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
B: Lamivudine 300 mg + Sorbitol 3.2 g
n=16 Participants
After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
C: Lamivudine 300 mg + Sorbitol 10.2 g
n=16 Participants
After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
D: Lamivudine 300 mg + Sorbitol 13.4 g
n=16 Participants
After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
|---|---|---|---|---|
|
Change From Baseline in Albumin
Day 3
|
1.8 G//L
Standard Deviation 2.43
|
2.3 G//L
Standard Deviation 1.58
|
2.1 G//L
Standard Deviation 2.38
|
2.1 G//L
Standard Deviation 2.09
|
|
Change From Baseline in Albumin
Follow up
|
0.6 G//L
Standard Deviation 1.63
|
0.6 G//L
Standard Deviation 1.63
|
0.6 G//L
Standard Deviation 1.63
|
0.6 G//L
Standard Deviation 1.63
|
Adverse Events
A: Lamivudine 300 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
B: Lamivudine 300 mg + Sorbitol 3.2 g
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
C: Lamivudine 300 mg + Sorbitol 10.2 g
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
D: Lamivudine 300 mg + Sorbitol 13.4 g
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 |
A: Lamivudine 300 mg
n=16 participants at risk
After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
B: Lamivudine 300 mg + Sorbitol 3.2 g
n=16 participants at risk
After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
C: Lamivudine 300 mg + Sorbitol 10.2 g
n=16 participants at risk
After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
D: Lamivudine 300 mg + Sorbitol 13.4 g
n=16 participants at risk
After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
|
|---|---|---|---|---|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/16 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 5 weeks).
On-treatment SAEs and non-serious AEs are reported for Safety Population.
|
6.2%
1/16 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 5 weeks).
On-treatment SAEs and non-serious AEs are reported for Safety Population.
|
0.00%
0/16 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 5 weeks).
On-treatment SAEs and non-serious AEs are reported for Safety Population.
|
0.00%
0/16 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 5 weeks).
On-treatment SAEs and non-serious AEs are reported for Safety Population.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/16 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 5 weeks).
On-treatment SAEs and non-serious AEs are reported for Safety Population.
|
0.00%
0/16 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 5 weeks).
On-treatment SAEs and non-serious AEs are reported for Safety Population.
|
0.00%
0/16 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 5 weeks).
On-treatment SAEs and non-serious AEs are reported for Safety Population.
|
6.2%
1/16 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 5 weeks).
On-treatment SAEs and non-serious AEs are reported for Safety Population.
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/16 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 5 weeks).
On-treatment SAEs and non-serious AEs are reported for Safety Population.
|
6.2%
1/16 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 5 weeks).
On-treatment SAEs and non-serious AEs are reported for Safety Population.
|
0.00%
0/16 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 5 weeks).
On-treatment SAEs and non-serious AEs are reported for Safety Population.
|
0.00%
0/16 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 5 weeks).
On-treatment SAEs and non-serious AEs are reported for Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.2%
1/16 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 5 weeks).
On-treatment SAEs and non-serious AEs are reported for Safety Population.
|
0.00%
0/16 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 5 weeks).
On-treatment SAEs and non-serious AEs are reported for Safety Population.
|
0.00%
0/16 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 5 weeks).
On-treatment SAEs and non-serious AEs are reported for Safety Population.
|
0.00%
0/16 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 5 weeks).
On-treatment SAEs and non-serious AEs are reported for Safety Population.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/16 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 5 weeks).
On-treatment SAEs and non-serious AEs are reported for Safety Population.
|
0.00%
0/16 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 5 weeks).
On-treatment SAEs and non-serious AEs are reported for Safety Population.
|
6.2%
1/16 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 5 weeks).
On-treatment SAEs and non-serious AEs are reported for Safety Population.
|
0.00%
0/16 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 5 weeks).
On-treatment SAEs and non-serious AEs are reported for Safety Population.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
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