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Bioequivalence Study of Mycophenolate Mofetil 250 mg Capsule Under Fasting Condition

NCT01080443 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2010-03-12

No results posted yet for this study

Summary

The objective of the study is to compare the bioavailability and characterise the pharmacokinetic profile of Mycophenolate mofetil 250 mg capsules Panacea Biotech Ltd, India and Cellcept® 250 mg capsules Mycophenolate mofetil capsule, Roche Labs Inc. New Jersey, USA in normal, healthy, adult human subjects under fasting conditions, and to assess the bioequivalence.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Mycophenolate Mofetil Capsule 250 mg

Subjects will be administered either Test Product or Reference Product with 240 mL of water according to randomization schedule

Sponsors & Collaborators

  • Panacea Biotec Ltd

    lead INDUSTRY

Principal Investigators

  • Dr. Pankaj K Jha · Lambda Therapeutic Research Ltd.

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2008-07-31
Completion
2008-07-31

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 NCT01080443 on ClinicalTrials.gov