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Bioequivalence Study of Lamotrigine ER 50 mg in Healthy Volunteers
NCT05145608Phase 1Completed
- Sponsor
- Alembic Pharmaceuticals Ltd.
- Start
- Jan 2018
- Primary completion
- Feb 2018
- Modality
- Small Molecules
- Countries
- 1
01
Overview
Phase 1, randomised, open-label trial of lamotrigine in epilepsy and bipolar disorder (BD) (2 arms), sponsored by Alembic Pharmaceuticals Ltd. Primary endpoints: Maximum Plasma Concentration up to 192 hours, Area Under the Curve to Last Timepoint up to 192 hours and 1 more. Started Jan 2018; status: completed.
02
Drugs
lamotrigine
03
Conditions
epilepsybipolar disorder (BD)
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