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Bioequivalence Study of Mycophenolate Mofetil 250 mg Capsule, Under Fed Conditions

NCT01513057 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2012-01-20

No results posted yet for this study

Summary

An open-label, balanced, randomized, two-treatment, two-period, two sequence, single dose, crossover, bioequivalence study of Mycophenolate mofetil 250 mg Capsule of Dr. Reddy's Laboratories limited, comparing with that of Cellcept 250 mg Capsule of Roche Laboratories in healthy, adult, human, male subjects under fed conditions.

Conditions

  • Healthy

Interventions

DRUG

Mycophenolate Mofetil

Mycophenolate Mofetil 250 mg capsules of Dr. Reddy's Laboratories Limited

DRUG

Mycophenolate Mofetil

250 mg capsules of Roche Laboratories Inc.

Sponsors & Collaborators

  • Dr. Reddy's Laboratories Limited

    lead INDUSTRY

Principal Investigators

  • Pankaj Kumar Jha, MD · Lambda Therapeutic Research Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2009-01-31
Completion
2009-02-28

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 NCT01513057 on ClinicalTrials.gov