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Bioequivalence Study for Donepezil Hydrochloride Tablets 10 mg Under Fed Condition

NCT01504516 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2012-01-06

No results posted yet for this study

Summary

This is an open label, balanced, randomized, two-treatment, two-period, two sequence, single dose, crossover, oral bioequivalence study.

Conditions

  • Healthy

Interventions

DRUG

Donepezil Hydrochloride

Donepezil Hydrochloride Tablets 10 mg

DRUG

Aricept

Aricept 10 mg Tablets

Sponsors & Collaborators

  • Dr. Reddy's Laboratories Limited

    lead INDUSTRY

Principal Investigators

  • Dr. L Krishna Murthy · Bioserve Clinical Research Private Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2009-11-30
Completion
2009-12-31

Countries

  • India

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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 NCT01504516 on ClinicalTrials.gov