NCT01419366

Bioequivalence Study of Torrent Pharmaceutical Limited's Donepezil Hydrochloride Tablets Under Fed Conditions

An Open Label, Randomized, 2-Period, 2-Treatment, Crossover, Single-Dose Bioequivalence Study of Donepezil Hydrochloride Tablets 10mg [Test Formulation, Torrent Pharmaceutical Limited., India] Versus Aricept® (Donepezil Hydrochloride) Tablets 10mg [Reference Formulation, Eisai Inc.), in Healthy Human Volunteers Under Fed Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: Torrent Pharmaceuticals Limited · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Objective: To compare the rate and extent of release of the drug substance from the two tablet formulation of Donepezil Hydrochloride Tablets 10mg of Torrent Pharmaceuticals Limited and the Aricept® Tablets 10mg of Eisai Inc., Dosing periods were separated by a washout period of at least 7 days. Study Design: Randomized, open label, two treatment, two period, two sequence, single dose, crossover study in healthy human adult subjects

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Torrent's Donepezil Hydrochloride Tablets 10mg

Timeline

• First posted: 2011-08-18
• Last updated: 2013-08-23

Locations

1 site across 1 country: India