Trial Outcomes & Findings for A Study Evaluating the Relative Bioavailability of Lofexidine Granules for Reconstitution Compared to LUCEMYRA (Lofexidine) Tablets and the Effect of Food on the Bioavailability of the Lofexidine Granules for Reconstitution (NCT NCT04188730)
NCT ID: NCT04188730
Last Updated: 2022-06-15
Results Overview
The peak exposure plasma concentrations (Cmax) of lofexidine were observed and measured.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
Mean from Day 1 through Day 3 for Periods I, II, III.
Results posted on
2022-06-15
Participant Flow
Participant milestones
| Measure |
Sequence 1: Treatment B, Treatment A, Treatment C
Treatment B = LUCEMYRA tablets - fasted conditions Treatment A = Lofexidine granules - fasted conditions Treatment C = Lofexidine granules - fed conditions Participants in Sequence 1 were first administered (Period 1) one 0.36 mg dose of LUCEMYRA (lofexidine) tablets following an overnight fast of at least 10 hours (Treatment B). Following a 7 day interval between doses, participants were administer (Period 2) one 0.36 mg dose of lofexidine granules for reconstitution following an overnight fast of at least 10 hours (Treatment A). Following a 7 day interval between doses, participants were administered (Period 3) one 0.36 mg dose of lofexidine granules for reconstitution, 30 minutes following a standardized high-fat, high-calorie breakfast preceded by an overnight fast of at least 10 hours (Treatment C).
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Sequence 2: Treatment B, Treatment C, Treatment A
Treatment B = LUCEMYRA tablets - fasted conditions Treatment C = Lofexidine granules - fed conditions Treatment A = Lofexidine granules - fasted conditions Participants in Sequence 2 were first administered (Period 1) one 0.36 mg dose of LUCEMYRA (lofexidine) tablets following an overnight fast of at least 10 hours (Treatment B). Following a 7 day interval between doses, participants were administer (Period 2) one 0.36 mg dose of lofexidine granules for reconstitution, 30 minutes following a standardized high-fat, high-calorie breakfast preceded by an overnight fast of at least 10 hours (Treatment C). Following a 7 day interval between doses, participants were administered (Period 3) one 0.36 mg dose of lofexidine granules for reconstitution following an overnight fast of at least 10 hours (Treatment A).
|
Sequence 3: Treatment A, Treatment C, Treatment B
Treatment A = Lofexidine granules - fasted conditions Treatment C = Lofexidine granules - fed conditions Treatment B = LUCEMYRA tablets - fasted conditions Participants in Sequence 3 were first administered (Period 1) one 0.36 mg dose of lofexidine granules for reconstitution following an overnight fast of at least 10 hours (Treatment A). Following a 7 day interval between doses, participants were administer (Period 2) one 0.36 mg dose of lofexidine granules for reconstitution, 30 minutes following a standardized high-fat, high-calorie breakfast preceded by an overnight fast of at least 10 hours (Treatment C). Following a 7 day interval between doses, participants were administered (Period 3) one 0.36 mg dose of LUCEMYRA (lofexidine) tablets following an overnight fast of at least 10 hours (Treatment B).
|
Sequence 4: Treatment C, Treatment A, Treatment B
Treatment C = Lofexidine granules - fed conditions Treatment A = Lofexidine granules - fasted conditions Treatment B = LUCEMYRA tablets - fasted conditions
Participants in Sequence 4 were first administered (Period 1) one 0.36 mg dose of lofexidine granules for reconstitution, 30 minutes following a standardized high-fat, high-calorie breakfast preceded by an overnight fast of at least 10 hours (Treatment C). Following a 7 day interval between doses, participants were administer (Period 2) one 0.36 mg dose of lofexidine granules for reconstitution following an overnight fast of at least 10 hours (Treatment A). Following a 7 day interval between doses, participants were administered (Period 3) one 0.36 mg dose of LUCEMYRA (lofexidine) tablets following an overnight fast of at least 10 hours (Treatment B).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
4
|
4
|
|
Overall Study
Period 1
|
4
|
4
|
4
|
4
|
|
Overall Study
Period 2
|
3
|
4
|
4
|
4
|
|
Overall Study
Period 3
|
3
|
4
|
4
|
4
|
|
Overall Study
COMPLETED
|
3
|
4
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study Evaluating the Relative Bioavailability of Lofexidine Granules for Reconstitution Compared to LUCEMYRA (Lofexidine) Tablets and the Effect of Food on the Bioavailability of the Lofexidine Granules for Reconstitution
Baseline characteristics by cohort
| Measure |
All Study Participants
n=16 Participants
16 individuals were enrolled in this crossover study. Each subject was eligible to participate in all 3 Treatment Groups (Treatment A, Treatment B, Treatment C).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Age, Continuous
|
35.1 years
STANDARD_DEVIATION 7.9 • n=93 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Body Mass Index (BMI)
|
28.5 kg/m^2
STANDARD_DEVIATION 3.2 • n=93 Participants
|
|
Height
|
175.1 cm
STANDARD_DEVIATION 8.4 • n=93 Participants
|
|
Weight
|
88.0 kg
STANDARD_DEVIATION 14.6 • n=93 Participants
|
|
Tobacco Users
Yes
|
0 Count of participants
n=93 Participants
|
|
Tobacco Users
No
|
16 Count of participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Mean from Day 1 through Day 3 for Periods I, II, III.Population: Only sufficient data for 15 of the 16 participants to be analyzed for Pharmacokinetic data due to one participant dropping out after Sequence 1 of the study.
The peak exposure plasma concentrations (Cmax) of lofexidine were observed and measured.
Outcome measures
| Measure |
Treatment A: Lofexidine Granules - Fasted Conditions
n=15 Participants
Participants will be administered lofexidine granules for reconstitution following an overnight fast of at least 10 hours.
Lofexidine (granules for reconstitution): All subjects will be administered one 0.36 mg dose of lofexidine granules for reconstitution.
|
Treatment B: LUCEMYRA Tablets - Fasted Conditions
n=15 Participants
Participants will first be administered LUCEMYRA (lofexidine) tablets following an overnight fast of at least 10 hours
LUCEMYRA (lofexidine) tablets: All subjects will be administered one 0.36 mg dose of LUCEMYRA (lofexidine) tablets.
|
Treatment C: Lofexidine Granules - Fed Conditions
n=15 Participants
Participants will first be administered lofexidine granules for reconstitution, 30 minutes following a standardized high-fat, high-calorie breakfast preceded by an overnight fast of at least 10 hours.
Lofexidine (granules for reconstitution): All subjects will be administered one 0.36 mg dose of lofexidine granules for reconstitution.
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|---|---|---|---|
|
Mean Maximum Plasma Concentration (Cmax)
|
0.6984 ng/mL
Standard Deviation 0.1661
|
0.7275 ng/mL
Standard Deviation 0.1657
|
0.6977 ng/mL
Standard Deviation 0.1656
|
PRIMARY outcome
Timeframe: Day 1 through Day 3 for Periods I, II, III.Population: Only sufficient data for 15 of the 16 participants to be analyzed for Pharmacokinetic data due to one participant dropping out after Sequence 1 of the study.
Time to peak plasma concentration (h) collection time at which Cmax is first observed.
Outcome measures
| Measure |
Treatment A: Lofexidine Granules - Fasted Conditions
n=15 Participants
Participants will be administered lofexidine granules for reconstitution following an overnight fast of at least 10 hours.
Lofexidine (granules for reconstitution): All subjects will be administered one 0.36 mg dose of lofexidine granules for reconstitution.
|
Treatment B: LUCEMYRA Tablets - Fasted Conditions
n=15 Participants
Participants will first be administered LUCEMYRA (lofexidine) tablets following an overnight fast of at least 10 hours
LUCEMYRA (lofexidine) tablets: All subjects will be administered one 0.36 mg dose of LUCEMYRA (lofexidine) tablets.
|
Treatment C: Lofexidine Granules - Fed Conditions
n=15 Participants
Participants will first be administered lofexidine granules for reconstitution, 30 minutes following a standardized high-fat, high-calorie breakfast preceded by an overnight fast of at least 10 hours.
Lofexidine (granules for reconstitution): All subjects will be administered one 0.36 mg dose of lofexidine granules for reconstitution.
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|---|---|---|---|
|
Time to Maximum Plasma Concentration (Tmax)
|
4.2678 hours
Standard Deviation 1.3894
|
4.3367 hours
Standard Deviation 1.2364
|
4.5344 hours
Standard Deviation 1.6435
|
PRIMARY outcome
Timeframe: Day 1 through Day 3 for Periods I, II, III.Population: Only sufficient data for 15 of the 16 participants to be analyzed for Pharmacokinetic data due to one participant dropping out after Sequence 1 of the study.
Areas under the plasma concentration-time curve from time zero to the time of last measurable concentration (AUC0-t)
Outcome measures
| Measure |
Treatment A: Lofexidine Granules - Fasted Conditions
n=15 Participants
Participants will be administered lofexidine granules for reconstitution following an overnight fast of at least 10 hours.
Lofexidine (granules for reconstitution): All subjects will be administered one 0.36 mg dose of lofexidine granules for reconstitution.
|
Treatment B: LUCEMYRA Tablets - Fasted Conditions
n=15 Participants
Participants will first be administered LUCEMYRA (lofexidine) tablets following an overnight fast of at least 10 hours
LUCEMYRA (lofexidine) tablets: All subjects will be administered one 0.36 mg dose of LUCEMYRA (lofexidine) tablets.
|
Treatment C: Lofexidine Granules - Fed Conditions
n=15 Participants
Participants will first be administered lofexidine granules for reconstitution, 30 minutes following a standardized high-fat, high-calorie breakfast preceded by an overnight fast of at least 10 hours.
Lofexidine (granules for reconstitution): All subjects will be administered one 0.36 mg dose of lofexidine granules for reconstitution.
|
|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Measurable Concentration (AUC0-t)
|
12.1333 h*ng/mL
Standard Deviation 4.965
|
12.2450 h*ng/mL
Standard Deviation 4.142
|
12.4540 h*ng/mL
Standard Deviation 4.517
|
PRIMARY outcome
Timeframe: Mean from Day 1 through Day 3 for Periods I, II, III.Population: Only sufficient data for 15 of the 16 participants to be analyzed for Pharmacokinetic data due to one participant dropping out after Sequence 1 of the study.
Outcome measures
| Measure |
Treatment A: Lofexidine Granules - Fasted Conditions
n=15 Participants
Participants will be administered lofexidine granules for reconstitution following an overnight fast of at least 10 hours.
Lofexidine (granules for reconstitution): All subjects will be administered one 0.36 mg dose of lofexidine granules for reconstitution.
|
Treatment B: LUCEMYRA Tablets - Fasted Conditions
n=15 Participants
Participants will first be administered LUCEMYRA (lofexidine) tablets following an overnight fast of at least 10 hours
LUCEMYRA (lofexidine) tablets: All subjects will be administered one 0.36 mg dose of LUCEMYRA (lofexidine) tablets.
|
Treatment C: Lofexidine Granules - Fed Conditions
n=15 Participants
Participants will first be administered lofexidine granules for reconstitution, 30 minutes following a standardized high-fat, high-calorie breakfast preceded by an overnight fast of at least 10 hours.
Lofexidine (granules for reconstitution): All subjects will be administered one 0.36 mg dose of lofexidine granules for reconstitution.
|
|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time Zero to Time Infinity (AUC0-∞)
|
14.9643 h·ng/mL
Standard Deviation 6.063
|
14.7229 h·ng/mL
Standard Deviation 4.411
|
14.9004 h·ng/mL
Standard Deviation 5.021
|
PRIMARY outcome
Timeframe: Mean from Day 1 through Day 3 for Periods I, II, III.Population: Only sufficient data for 15 of the 16 participants to be analyzed for Pharmacokinetic data due to one participant dropping out after Sequence 1 of the study.
Outcome measures
| Measure |
Treatment A: Lofexidine Granules - Fasted Conditions
n=15 Participants
Participants will be administered lofexidine granules for reconstitution following an overnight fast of at least 10 hours.
Lofexidine (granules for reconstitution): All subjects will be administered one 0.36 mg dose of lofexidine granules for reconstitution.
|
Treatment B: LUCEMYRA Tablets - Fasted Conditions
n=15 Participants
Participants will first be administered LUCEMYRA (lofexidine) tablets following an overnight fast of at least 10 hours
LUCEMYRA (lofexidine) tablets: All subjects will be administered one 0.36 mg dose of LUCEMYRA (lofexidine) tablets.
|
Treatment C: Lofexidine Granules - Fed Conditions
n=15 Participants
Participants will first be administered lofexidine granules for reconstitution, 30 minutes following a standardized high-fat, high-calorie breakfast preceded by an overnight fast of at least 10 hours.
Lofexidine (granules for reconstitution): All subjects will be administered one 0.36 mg dose of lofexidine granules for reconstitution.
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|---|---|---|---|
|
First-order Terminal Rate Constant (λz)
|
0.0549 h^-1
Standard Deviation 0.0150
|
0.0524 h^-1
Standard Deviation 0.0071
|
0.0524 h^-1
Standard Deviation 0.0075
|
PRIMARY outcome
Timeframe: Mean from Day 1 through Day 3 for Periods I, II, III.Population: Only sufficient data for 15 of the 16 participants to be analyzed for Pharmacokinetic data due to one participant dropping out after Sequence 1 of the study.
Outcome measures
| Measure |
Treatment A: Lofexidine Granules - Fasted Conditions
n=15 Participants
Participants will be administered lofexidine granules for reconstitution following an overnight fast of at least 10 hours.
Lofexidine (granules for reconstitution): All subjects will be administered one 0.36 mg dose of lofexidine granules for reconstitution.
|
Treatment B: LUCEMYRA Tablets - Fasted Conditions
n=15 Participants
Participants will first be administered LUCEMYRA (lofexidine) tablets following an overnight fast of at least 10 hours
LUCEMYRA (lofexidine) tablets: All subjects will be administered one 0.36 mg dose of LUCEMYRA (lofexidine) tablets.
|
Treatment C: Lofexidine Granules - Fed Conditions
n=15 Participants
Participants will first be administered lofexidine granules for reconstitution, 30 minutes following a standardized high-fat, high-calorie breakfast preceded by an overnight fast of at least 10 hours.
Lofexidine (granules for reconstitution): All subjects will be administered one 0.36 mg dose of lofexidine granules for reconstitution.
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|---|---|---|---|
|
First-order Terminal Half-life (T½)
|
13.5577 hours
Standard Deviation 3.901
|
13.4681 hours
Standard Deviation 1.881
|
13.5008 hours
Standard Deviation 2.068
|
SECONDARY outcome
Timeframe: Total from occurrences assessed daily after each dosing for Periods 1-3, as well as end of study (22 days)Number of Subjects dosed for each Treatment groups: Treatment A = 15 subjects dosed; Treatment B = 16 subjects dosed; Treatment C = 15 subjects dosed
Outcome measures
| Measure |
Treatment A: Lofexidine Granules - Fasted Conditions
n=15 Participants
Participants will be administered lofexidine granules for reconstitution following an overnight fast of at least 10 hours.
Lofexidine (granules for reconstitution): All subjects will be administered one 0.36 mg dose of lofexidine granules for reconstitution.
|
Treatment B: LUCEMYRA Tablets - Fasted Conditions
n=16 Participants
Participants will first be administered LUCEMYRA (lofexidine) tablets following an overnight fast of at least 10 hours
LUCEMYRA (lofexidine) tablets: All subjects will be administered one 0.36 mg dose of LUCEMYRA (lofexidine) tablets.
|
Treatment C: Lofexidine Granules - Fed Conditions
n=15 Participants
Participants will first be administered lofexidine granules for reconstitution, 30 minutes following a standardized high-fat, high-calorie breakfast preceded by an overnight fast of at least 10 hours.
Lofexidine (granules for reconstitution): All subjects will be administered one 0.36 mg dose of lofexidine granules for reconstitution.
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|---|---|---|---|
|
Occurrence of Adverse Events (AEs)
|
3 adverse events
|
13 adverse events
|
14 adverse events
|
Adverse Events
Treatment A: Lofexidine Granules - Fasted Conditions
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Treatment B: LUCEMYRA Tablets - Fasted Conditions
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Treatment C: Lofexidine Granules - Fed Conditions
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment A: Lofexidine Granules - Fasted Conditions
n=15 participants at risk
Participants were administer one-0.36 mg dose of Lofexidine granules for reconstitution following an overnight fast of at least 10 hours.
|
Treatment B: LUCEMYRA Tablets - Fasted Conditions
n=16 participants at risk
Participants will first be administered one-0.36 mg dose of LUCEMYRA (lofexidine) tablets following an overnight fast of at least 10 hours.
|
Treatment C: Lofexidine Granules - Fed Conditions
n=15 participants at risk
Participants will first be administered one-0.36 mg dose of lofexidine granules for reconstitution, 30 minutes following a standardized high-fat, high-calorie breakfast preceded by an overnight fast of at least 10 hours.
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|---|---|---|---|
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Investigations
Blood pressure decreased
|
13.3%
2/15 • Daily after each dosing for Periods 1-3, as well as End of Study Day 3 Period 3 (22 days)
Number of Subjects dosed for each Treatment groups: Treatment A = 15 subjects dosed; Treatment B = 16 subjects dosed; Treatment C = 15 subjects dosed
|
25.0%
4/16 • Daily after each dosing for Periods 1-3, as well as End of Study Day 3 Period 3 (22 days)
Number of Subjects dosed for each Treatment groups: Treatment A = 15 subjects dosed; Treatment B = 16 subjects dosed; Treatment C = 15 subjects dosed
|
26.7%
4/15 • Daily after each dosing for Periods 1-3, as well as End of Study Day 3 Period 3 (22 days)
Number of Subjects dosed for each Treatment groups: Treatment A = 15 subjects dosed; Treatment B = 16 subjects dosed; Treatment C = 15 subjects dosed
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/15 • Daily after each dosing for Periods 1-3, as well as End of Study Day 3 Period 3 (22 days)
Number of Subjects dosed for each Treatment groups: Treatment A = 15 subjects dosed; Treatment B = 16 subjects dosed; Treatment C = 15 subjects dosed
|
0.00%
0/16 • Daily after each dosing for Periods 1-3, as well as End of Study Day 3 Period 3 (22 days)
Number of Subjects dosed for each Treatment groups: Treatment A = 15 subjects dosed; Treatment B = 16 subjects dosed; Treatment C = 15 subjects dosed
|
6.7%
1/15 • Daily after each dosing for Periods 1-3, as well as End of Study Day 3 Period 3 (22 days)
Number of Subjects dosed for each Treatment groups: Treatment A = 15 subjects dosed; Treatment B = 16 subjects dosed; Treatment C = 15 subjects dosed
|
|
Nervous system disorders
Somnolence
|
6.7%
1/15 • Daily after each dosing for Periods 1-3, as well as End of Study Day 3 Period 3 (22 days)
Number of Subjects dosed for each Treatment groups: Treatment A = 15 subjects dosed; Treatment B = 16 subjects dosed; Treatment C = 15 subjects dosed
|
25.0%
4/16 • Daily after each dosing for Periods 1-3, as well as End of Study Day 3 Period 3 (22 days)
Number of Subjects dosed for each Treatment groups: Treatment A = 15 subjects dosed; Treatment B = 16 subjects dosed; Treatment C = 15 subjects dosed
|
20.0%
3/15 • Daily after each dosing for Periods 1-3, as well as End of Study Day 3 Period 3 (22 days)
Number of Subjects dosed for each Treatment groups: Treatment A = 15 subjects dosed; Treatment B = 16 subjects dosed; Treatment C = 15 subjects dosed
|
|
Nervous system disorders
Dizziness
|
0.00%
0/15 • Daily after each dosing for Periods 1-3, as well as End of Study Day 3 Period 3 (22 days)
Number of Subjects dosed for each Treatment groups: Treatment A = 15 subjects dosed; Treatment B = 16 subjects dosed; Treatment C = 15 subjects dosed
|
6.2%
1/16 • Daily after each dosing for Periods 1-3, as well as End of Study Day 3 Period 3 (22 days)
Number of Subjects dosed for each Treatment groups: Treatment A = 15 subjects dosed; Treatment B = 16 subjects dosed; Treatment C = 15 subjects dosed
|
0.00%
0/15 • Daily after each dosing for Periods 1-3, as well as End of Study Day 3 Period 3 (22 days)
Number of Subjects dosed for each Treatment groups: Treatment A = 15 subjects dosed; Treatment B = 16 subjects dosed; Treatment C = 15 subjects dosed
|
|
Nervous system disorders
Headache
|
0.00%
0/15 • Daily after each dosing for Periods 1-3, as well as End of Study Day 3 Period 3 (22 days)
Number of Subjects dosed for each Treatment groups: Treatment A = 15 subjects dosed; Treatment B = 16 subjects dosed; Treatment C = 15 subjects dosed
|
6.2%
1/16 • Daily after each dosing for Periods 1-3, as well as End of Study Day 3 Period 3 (22 days)
Number of Subjects dosed for each Treatment groups: Treatment A = 15 subjects dosed; Treatment B = 16 subjects dosed; Treatment C = 15 subjects dosed
|
0.00%
0/15 • Daily after each dosing for Periods 1-3, as well as End of Study Day 3 Period 3 (22 days)
Number of Subjects dosed for each Treatment groups: Treatment A = 15 subjects dosed; Treatment B = 16 subjects dosed; Treatment C = 15 subjects dosed
|
|
Nervous system disorders
Presyncope
|
0.00%
0/15 • Daily after each dosing for Periods 1-3, as well as End of Study Day 3 Period 3 (22 days)
Number of Subjects dosed for each Treatment groups: Treatment A = 15 subjects dosed; Treatment B = 16 subjects dosed; Treatment C = 15 subjects dosed
|
6.2%
1/16 • Daily after each dosing for Periods 1-3, as well as End of Study Day 3 Period 3 (22 days)
Number of Subjects dosed for each Treatment groups: Treatment A = 15 subjects dosed; Treatment B = 16 subjects dosed; Treatment C = 15 subjects dosed
|
0.00%
0/15 • Daily after each dosing for Periods 1-3, as well as End of Study Day 3 Period 3 (22 days)
Number of Subjects dosed for each Treatment groups: Treatment A = 15 subjects dosed; Treatment B = 16 subjects dosed; Treatment C = 15 subjects dosed
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/15 • Daily after each dosing for Periods 1-3, as well as End of Study Day 3 Period 3 (22 days)
Number of Subjects dosed for each Treatment groups: Treatment A = 15 subjects dosed; Treatment B = 16 subjects dosed; Treatment C = 15 subjects dosed
|
6.2%
1/16 • Daily after each dosing for Periods 1-3, as well as End of Study Day 3 Period 3 (22 days)
Number of Subjects dosed for each Treatment groups: Treatment A = 15 subjects dosed; Treatment B = 16 subjects dosed; Treatment C = 15 subjects dosed
|
6.7%
1/15 • Daily after each dosing for Periods 1-3, as well as End of Study Day 3 Period 3 (22 days)
Number of Subjects dosed for each Treatment groups: Treatment A = 15 subjects dosed; Treatment B = 16 subjects dosed; Treatment C = 15 subjects dosed
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/15 • Daily after each dosing for Periods 1-3, as well as End of Study Day 3 Period 3 (22 days)
Number of Subjects dosed for each Treatment groups: Treatment A = 15 subjects dosed; Treatment B = 16 subjects dosed; Treatment C = 15 subjects dosed
|
0.00%
0/16 • Daily after each dosing for Periods 1-3, as well as End of Study Day 3 Period 3 (22 days)
Number of Subjects dosed for each Treatment groups: Treatment A = 15 subjects dosed; Treatment B = 16 subjects dosed; Treatment C = 15 subjects dosed
|
6.7%
1/15 • Daily after each dosing for Periods 1-3, as well as End of Study Day 3 Period 3 (22 days)
Number of Subjects dosed for each Treatment groups: Treatment A = 15 subjects dosed; Treatment B = 16 subjects dosed; Treatment C = 15 subjects dosed
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/15 • Daily after each dosing for Periods 1-3, as well as End of Study Day 3 Period 3 (22 days)
Number of Subjects dosed for each Treatment groups: Treatment A = 15 subjects dosed; Treatment B = 16 subjects dosed; Treatment C = 15 subjects dosed
|
0.00%
0/16 • Daily after each dosing for Periods 1-3, as well as End of Study Day 3 Period 3 (22 days)
Number of Subjects dosed for each Treatment groups: Treatment A = 15 subjects dosed; Treatment B = 16 subjects dosed; Treatment C = 15 subjects dosed
|
6.7%
1/15 • Daily after each dosing for Periods 1-3, as well as End of Study Day 3 Period 3 (22 days)
Number of Subjects dosed for each Treatment groups: Treatment A = 15 subjects dosed; Treatment B = 16 subjects dosed; Treatment C = 15 subjects dosed
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/15 • Daily after each dosing for Periods 1-3, as well as End of Study Day 3 Period 3 (22 days)
Number of Subjects dosed for each Treatment groups: Treatment A = 15 subjects dosed; Treatment B = 16 subjects dosed; Treatment C = 15 subjects dosed
|
6.2%
1/16 • Daily after each dosing for Periods 1-3, as well as End of Study Day 3 Period 3 (22 days)
Number of Subjects dosed for each Treatment groups: Treatment A = 15 subjects dosed; Treatment B = 16 subjects dosed; Treatment C = 15 subjects dosed
|
0.00%
0/15 • Daily after each dosing for Periods 1-3, as well as End of Study Day 3 Period 3 (22 days)
Number of Subjects dosed for each Treatment groups: Treatment A = 15 subjects dosed; Treatment B = 16 subjects dosed; Treatment C = 15 subjects dosed
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/15 • Daily after each dosing for Periods 1-3, as well as End of Study Day 3 Period 3 (22 days)
Number of Subjects dosed for each Treatment groups: Treatment A = 15 subjects dosed; Treatment B = 16 subjects dosed; Treatment C = 15 subjects dosed
|
0.00%
0/16 • Daily after each dosing for Periods 1-3, as well as End of Study Day 3 Period 3 (22 days)
Number of Subjects dosed for each Treatment groups: Treatment A = 15 subjects dosed; Treatment B = 16 subjects dosed; Treatment C = 15 subjects dosed
|
13.3%
2/15 • Daily after each dosing for Periods 1-3, as well as End of Study Day 3 Period 3 (22 days)
Number of Subjects dosed for each Treatment groups: Treatment A = 15 subjects dosed; Treatment B = 16 subjects dosed; Treatment C = 15 subjects dosed
|
|
General disorders
Pain
|
0.00%
0/15 • Daily after each dosing for Periods 1-3, as well as End of Study Day 3 Period 3 (22 days)
Number of Subjects dosed for each Treatment groups: Treatment A = 15 subjects dosed; Treatment B = 16 subjects dosed; Treatment C = 15 subjects dosed
|
0.00%
0/16 • Daily after each dosing for Periods 1-3, as well as End of Study Day 3 Period 3 (22 days)
Number of Subjects dosed for each Treatment groups: Treatment A = 15 subjects dosed; Treatment B = 16 subjects dosed; Treatment C = 15 subjects dosed
|
6.7%
1/15 • Daily after each dosing for Periods 1-3, as well as End of Study Day 3 Period 3 (22 days)
Number of Subjects dosed for each Treatment groups: Treatment A = 15 subjects dosed; Treatment B = 16 subjects dosed; Treatment C = 15 subjects dosed
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place