Overview

Comparative Bioavailability Study of Lamotrigine ER Tablets USP 50 mg

Status:
Completed
Trial end date:
2018-02-21
Target enrollment:
Participant gender:
Summary
Objective: To evaluate and compare the bioavailability and therefore to assess the bioequivalence of two different formulations of lamotrigine after a single oral dose administration under fasting conditions. The secondary objective is to monitor the safety of the subjects.
Phase:
Phase 1
Details
Lead Sponsor:
Alembic Pharmaceuticals Ltd.
Treatments:
Anticonvulsants
Lamotrigine