Bioequivalence Study of Sodium Valproate and Valproic Acid Tablets

PHASE4Active, not recruitingINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

August 6, 2023

Primary Completion Date

October 13, 2023

Study Completion Date

November 30, 2023

Conditions
Epilepsy
Interventions
DRUG

Sodium valproate and valproic acid extended release tablet

Test or innovator tablet formulation of sodium valproate and valproic acid will be administered orally to the volunteers on each study days in fasting condition. Volunteers will be receiving a single tablet of either of the formulations on the study days by a randomization technique so that each of them receives both formulations during the study period.

Trial Locations (2)

Unknown

Department of Pharmacy, Kathmandu University, Dhulikhel

Dhulikhel Hospital, Kathmandu University Teaching Hospital, Dhulikhel

Sponsors
All Listed Sponsors
collaborator

Asian Pharmaceuticals Pvt. Ltd.

INDUSTRY

lead

Kathmandu University

OTHER

NCT05641649 - Bioequivalence Study of Sodium Valproate and Valproic Acid Tablets | Biotech Hunter | Biotech Hunter