Trial Outcomes & Findings for Lamotrigine Bioequivalence (NCT NCT01995825)

NCT ID: NCT01995825

Last Updated: 2020-12-01

Results Overview

pharmacokinetic exposure (ng\*hr/ml)

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 35 participants
• Primary outcome timeframe: 0-12hr
• Results posted on: 2020-12-01

Participant Flow

Participant milestones

Measure	Brand Lamotrigine Then Generic Lamotrigine Crossover trial. Each arm will receive Brand lamotrigine tablet for two periods and Generic lamotrigine for two periods.	Generic Lamotrigine Then Brand Lamotrigine Crossover trial. Each arm will receive Generic lamotrigine tablet for two periods and Brand lamotrigine for two periods.
Overall Study STARTED	18	17
Overall Study COMPLETED	17	17
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Brand Lamotrigine Then Generic Lamotrigine Crossover trial. Each arm will receive Brand lamotrigine tablet for two periods and Generic lamotrigine for two periods.	Generic Lamotrigine Then Brand Lamotrigine Crossover trial. Each arm will receive Generic lamotrigine tablet for two periods and Brand lamotrigine for two periods.
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Lamotrigine Bioequivalence

Baseline characteristics by cohort

Measure	Brand Lamotrigine Then Generic Lamotrigine n=18 Participants Crossover trial. Each arm will receive Brand lamotrigine tablet for two periods and Generic lamotrigine for two periods.	Generic Lamotrigine Then Brand Lamotrigine n=17 Participants Crossover trial. Each arm will receive Generic lamotrigine tablet for two periods and Brand lamotrigine for two periods.	Total n=35 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants	17 Participants n=7 Participants	34 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants

PRIMARY outcome

Timeframe: 0-12hr

pharmacokinetic exposure (ng*hr/ml)

Outcome measures

Measure	Brand Lamotrigine n=34 Participants Brand lamotrigine tablet100mg tablets (1-3 either once or twice a day) for two weeks	Generic Lamotrigine n=34 Participants Generic lamotrigine tablet100mg tablets (1-3 either once or twice a day) for two weeks
AUC	101346 ng*hr/ml Standard Error 6314	101393 ng*hr/ml Standard Error 6421

PRIMARY outcome

Timeframe: 0-12hr

highest concentration over the time duration 0-12hr (ng/ml)

Outcome measures

Measure	Brand Lamotrigine n=34 Participants Brand lamotrigine tablet100mg tablets (1-3 either once or twice a day) for two weeks	Generic Lamotrigine n=34 Participants Generic lamotrigine tablet100mg tablets (1-3 either once or twice a day) for two weeks
Cmax	10670 ng/ml Standard Error 657	10697 ng/ml Standard Error 717

Adverse Events

Brand Lamotrigine

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Generic Lamotrigine

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Brand Lamotrigine n=35 participants at risk Brand lamotrigine tablet 100mg tablets (1-3 either once or twice a day) for two weeks	Generic Lamotrigine n=35 participants at risk Generic lamotrigine tablet100mg tablets (1-3 either once or twice a day) for two weeks
Nervous system disorders headache	11.4% 4/35 • Number of events 8 • 8 weeks	11.4% 4/35 • Number of events 5 • 8 weeks
Nervous system disorders dizziness	5.7% 2/35 • Number of events 3 • 8 weeks	5.7% 2/35 • Number of events 4 • 8 weeks
General disorders nausea	5.7% 2/35 • Number of events 2 • 8 weeks	2.9% 1/35 • Number of events 2 • 8 weeks
Skin and subcutaneous tissue disorders rash	2.9% 1/35 • Number of events 1 • 8 weeks	2.9% 1/35 • Number of events 1 • 8 weeks
Ear and labyrinth disorders blurred vision	2.9% 1/35 • Number of events 1 • 8 weeks	2.9% 1/35 • Number of events 1 • 8 weeks
Gastrointestinal disorders vomiting	0.00% 0/35 • 8 weeks	2.9% 1/35 • Number of events 1 • 8 weeks

Additional Information

James Polli

U of Maryland

Phone: 410-706-8292

Email: jpolli@rx.umaryland.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place