Trial Outcomes & Findings for Bioequivalence Study of 200 mg Lamotrigine Tablet Under Non-Fasting Conditions (NCT NCT00835263)

NCT ID: NCT00835263

Last Updated: 2024-08-19

Results Overview

Bioequivalence based on Cmax

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 32 participants
• Primary outcome timeframe: Blood samples collected over 120 hour period
• Results posted on: 2024-08-19

Participant Flow

Participant milestones

Measure	Lamotrigine (Test) First Lamotrigine 200 mg Tablet (test) dosed in first period followed by Lamictal® 200 mg Tablet (reference) dosed in second period	Lamictal® (Reference) First Lamictal® 200 mg Tablet (reference) dosed in first period followed by Lamotrigine 200 mg Tablet (test) dosed in second period
First Intervention STARTED	16	16
First Intervention COMPLETED	16	16
First Intervention NOT COMPLETED	0	0
Second Intervention STARTED	16	16
Second Intervention COMPLETED	15	16
Second Intervention NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Lamotrigine (Test) First Lamotrigine 200 mg Tablet (test) dosed in first period followed by Lamictal® 200 mg Tablet (reference) dosed in second period	Lamictal® (Reference) First Lamictal® 200 mg Tablet (reference) dosed in first period followed by Lamotrigine 200 mg Tablet (test) dosed in second period
Second Intervention Adverse Event	1	0

Baseline Characteristics

Bioequivalence Study of 200 mg Lamotrigine Tablet Under Non-Fasting Conditions

Baseline characteristics by cohort

Measure	Lamotrigine (Test) First n=16 Participants Lamotrigine 200 mg Tablet (test) dosed in first period followed by Lamictal® 200 mg Tablet (reference) dosed in second period	Lamictal® (Reference) First n=16 Participants Lamictal® 200 mg Tablet (reference) dosed in first period followed by Lamotrigine 200 mg Tablet (test) dosed in second period	Total n=32 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	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	16 Participants n=5 Participants	15 Participants n=7 Participants	31 Participants n=5 Participants
Race/Ethnicity, Customized American Hispanic	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment Canada	16 participants n=5 Participants	16 participants n=7 Participants	32 participants n=5 Participants

PRIMARY outcome

Timeframe: Blood samples collected over 120 hour period

Population: Data from all subjects who completed the study were included in the statistical analysis.

Bioequivalence based on Cmax

Outcome measures

Measure	Lamotrigine n=31 Participants Lamotrigine 200 mg Tablet (test) dosed in either period	Lamictal® n=31 Participants Lamictal® 200 mg Tablet (reference) dosed in either period
Cmax - Maximum Observed Concentration	2518.00 ng/mL Standard Deviation 352.74	2442.49 ng/mL Standard Deviation 369.68

PRIMARY outcome

Timeframe: Blood samples collected over 120 hour period

Population: Data from all subjects who completed the study were included in the statistical analysis.

Bioequivalence based on AUC0-inf

Outcome measures

Measure	Lamotrigine n=31 Participants Lamotrigine 200 mg Tablet (test) dosed in either period	Lamictal® n=31 Participants Lamictal® 200 mg Tablet (reference) dosed in either period
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)	131594.33 ng*h/mL Standard Deviation 53082.11	126071.99 ng*h/mL Standard Deviation 46199.29

PRIMARY outcome

Timeframe: Blood samples collected over 120 hour period

Population: Data from all subjects who completed the study were included in the statistical analysis.

Bioequivalence based on AUC0-t

Outcome measures

Measure	Lamotrigine n=31 Participants Lamotrigine 200 mg Tablet (test) dosed in either period	Lamictal® n=31 Participants Lamictal® 200 mg Tablet (reference) dosed in either period
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)	113029.41 ng*h/mL Standard Deviation 34347.88	110324.30 ng*h/mL Standard Deviation 32081.83

Adverse Events

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Manager, Biopharmaceutics

Teva Pharmaceuticals USA

Phone: 1-866-384-5525

Email: clinicaltrialqueries@tevausa.com

Results disclosure agreements

• Principal investigator is a sponsor employee Principal Investigator is not permitted to discuss or publish trial results.
• Publication restrictions are in place

Restriction type: OTHER