Comparative Bioavailability Study of Lamotrigine ER Tablets USP 50 mg

PHASE1CompletedINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

January 10, 2018

Primary Completion Date

February 21, 2018

Study Completion Date

February 21, 2018

Conditions
Bioequivalence
Interventions
DRUG

Lamotrigine ER tablet 50mg

In each study period, a single 50 mg dose of lamotrigine will be administered orally with about 240 mL of water at ambient temperature, in the morning, while subjects are seated, following a 10-hour overnight fast.

Trial Locations (1)

H3P 3P1

Algorithme Pharma, Mount Royal

Sponsors
All Listed Sponsors
lead

Alembic Pharmaceuticals Ltd.

INDUSTRY

NCT05145608 - Comparative Bioavailability Study of Lamotrigine ER Tablets USP 50 mg | Biotech Hunter | Biotech Hunter