Trial Outcomes & Findings for Clinical Study of Generic and Brand Bupropion in Depression (NCT NCT02209597)
NCT ID: NCT02209597
Last Updated: 2020-04-24
Results Overview
Area under the curve (AUC) generic/Area under the curve (AUC) brand bupropion
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
74 participants
Primary outcome timeframe
For 24 hours approximately every 6 weeks
Results posted on
2020-04-24
Participant Flow
Participant milestones
| Measure |
Bupropion
Phase 1: (Non-randomized) an approximately 4-week lead-in phase during which participants remain on their existing bupropion product
Other Names:
Wellbutrin Par Mylan Valeant
|
|---|---|
|
Phase 1 Current Tx (Non-randomized)
STARTED
|
74
|
|
Phase 1 Current Tx (Non-randomized)
COMPLETED
|
71
|
|
Phase 1 Current Tx (Non-randomized)
NOT COMPLETED
|
3
|
|
Phase 2 (Randomized: 1 Brand, 3 Generic)
STARTED
|
71
|
|
Phase 2 (Randomized: 1 Brand, 3 Generic)
COMPLETED
|
67
|
|
Phase 2 (Randomized: 1 Brand, 3 Generic)
NOT COMPLETED
|
4
|
|
Phase 3 (Randomized: 1 Brand, 3 Generic)
STARTED
|
67
|
|
Phase 3 (Randomized: 1 Brand, 3 Generic)
COMPLETED
|
67
|
|
Phase 3 (Randomized: 1 Brand, 3 Generic)
NOT COMPLETED
|
0
|
|
Phase 4 (Randomized: 1 Brand, 3 Generic)
STARTED
|
67
|
|
Phase 4 (Randomized: 1 Brand, 3 Generic)
COMPLETED
|
67
|
|
Phase 4 (Randomized: 1 Brand, 3 Generic)
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
Bupropion
Phase 1: (Non-randomized) an approximately 4-week lead-in phase during which participants remain on their existing bupropion product
Other Names:
Wellbutrin Par Mylan Valeant
|
|---|---|
|
Phase 1 Current Tx (Non-randomized)
Withdrawal by Subject
|
2
|
|
Phase 1 Current Tx (Non-randomized)
Adverse Event
|
1
|
|
Phase 2 (Randomized: 1 Brand, 3 Generic)
Withdrawal by Subject
|
3
|
|
Phase 2 (Randomized: 1 Brand, 3 Generic)
Adverse Event
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Bupropion
n=70 Participants
Subjects will be studied for 28 weeks in a sequential cross-over study:
1. a 4-week lead-in phase during which all participants remain on their existing bupropion product
2. Four randomized cross-over phases of 6 weeks on each of the four bupropion study drugs (brand Wellbutrin 300mg XL, Valeant, Par and Watson 3 generics)
|
|---|---|
|
Age, Continuous
|
47 years
n=70 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=70 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=70 Participants
|
PRIMARY outcome
Timeframe: For 24 hours approximately every 6 weeksArea under the curve (AUC) generic/Area under the curve (AUC) brand bupropion
Outcome measures
| Measure |
Valeant Brand Bupropion XL® 300mg
n=67 Participants
Phase 1: an approximately 4-week lead-in phase during which participants remain on their existing bupropion product Phases 2 - 4: randomized cross-over phases of approximately 6 weeks on each of the four bupropion study drugs (brand and 3 generics).
|
Par Generic Bupropion XL® 300mg
n=67 Participants
Phase 1: an approximately 4-week lead-in phase during which participants remain on their existing bupropion product Phases 2 - 4: randomized cross-over phases of approximately 6 weeks on each of the four bupropion study drugs (brand and 3 generics).
|
Watson Generic Bupropion XL® 300mg
n=67 Participants
Phase 1: an approximately 4-week lead-in phase during which participants remain on their existing bupropion product Phases 2 - 4: randomized cross-over phases of approximately 6 weeks on each of the four bupropion study drugs (brand and 3 generics).
|
Mylan Generic Bupropion XL® 300mg
n=67 Participants
Phase 1: an approximately 4-week lead-in phase during which participants remain on their existing bupropion product Phases 2 - 4: randomized cross-over phases of approximately 6 weeks on each of the four bupropion study drugs (brand and 3 generics).
|
|---|---|---|---|---|
|
Area Under the Curve (AUC0-24) Ratio for Racemic Bupropion
Bupropion
|
.84 percentage of Brand
Interval 0.71 to 1.04
|
.88 percentage of Brand
Interval 0.72 to 1.08
|
.83 percentage of Brand
Interval 0.68 to 0.99
|
.89 percentage of Brand
Interval 0.7 to 1.06
|
|
Area Under the Curve (AUC0-24) Ratio for Racemic Bupropion
Hydroxybupropion
|
20.9 percentage of Brand
Interval 15.5 to 25.5
|
20.9 percentage of Brand
Interval 15.9 to 28.1
|
21.8 percentage of Brand
Interval 15.9 to 26.5
|
21.6 percentage of Brand
Interval 15.9 to 27.7
|
|
Area Under the Curve (AUC0-24) Ratio for Racemic Bupropion
Erthrohydrobuprion
|
2.09 percentage of Brand
Interval 1.52 to 2.59
|
2.05 percentage of Brand
Interval 1.47 to 2.57
|
1.98 percentage of Brand
Interval 1.48 to 2.34
|
2.02 percentage of Brand
Interval 1.61 to 2.5
|
|
Area Under the Curve (AUC0-24) Ratio for Racemic Bupropion
Threohydrobupropion
|
9.38 percentage of Brand
Interval 7.21 to 13.27
|
9.05 percentage of Brand
Interval 7.21 to 13.27
|
8.57 percentage of Brand
Interval 6.83 to 11.57
|
8.78 percentage of Brand
Interval 7.25 to 12.49
|
Adverse Events
Valeant Brand Bupropion XL® 300mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PAR Generic Bupropion XL® 300mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Watson Generic Bupropion XL® 300mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Mylan Generic Bupropion XL® 300mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Valeant Brand Bupropion XL® 300mg
n=71 participants at risk
Phase 1: an approximately 4-week lead-in phase during which participants remain on their existing bupropion product Phases 2 - 4: randomized cross-over phases of approximately 6 weeks on each of the four bupropion study drugs (brand and 3 generics).
|
PAR Generic Bupropion XL® 300mg
n=71 participants at risk
Phase 1: an approximately 4-week lead-in phase during which participants remain on their existing bupropion product Phases 2 - 4: randomized cross-over phases of approximately 6 weeks on each of the four bupropion study drugs (brand and 3 generics).
|
Watson Generic Bupropion XL® 300mg
n=71 participants at risk
Phase 1: an approximately 4-week lead-in phase during which participants remain on their existing bupropion product Phases 2 - 4: randomized cross-over phases of approximately 6 weeks on each of the four bupropion study drugs (brand and 3 generics).
|
Mylan Generic Bupropion XL® 300mg
n=71 participants at risk
Phase 1: an approximately 4-week lead-in phase during which participants remain on their existing bupropion product Phases 2 - 4: randomized cross-over phases of approximately 6 weeks on each of the four bupropion study drugs (brand and 3 generics).
|
|---|---|---|---|---|
|
Nervous system disorders
depression
|
0.00%
0/71 • 28 weeks
|
0.00%
0/71 • 28 weeks
|
1.4%
1/71 • Number of events 1 • 28 weeks
|
0.00%
0/71 • 28 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place