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

NCT01419366 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2013-08-23

No results posted yet for this study

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

DRUG

Torrent's Donepezil Hydrochloride Tablets 10mg

Sponsors & Collaborators

  • Torrent Pharmaceuticals Limited

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01419366 on ClinicalTrials.gov