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Bioequivalency Study of Mycophenolate Mofetil 250 mg Capsules Under Fed Conditions

This study has been completed.
Sponsor:
Information provided by:
Roxane Laboratories
ClinicalTrials.gov Identifier:
NCT00893919
First received: May 4, 2009
Last updated: October 9, 2009
Last verified: October 2009
History of Changes
  Purpose

The objective of this study was to prove the bioequivalence of Mycophenolate Mofetil 250 mg Capsules under fed conditions.


Condition Intervention
Prophylaxis of Organ Rejection
 Drug: mycophenolate mofetil

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single Dose, 2-Period, 2-Treatment 2-Way Crossover Bioequivalency Study of Mycophenolate Mofetil 250 mg Capsules Under Fed Conditions

Resource links provided by NLM:

MedlinePlus related topics: Malnutrition
U.S. FDA Resources

Further study details as provided by Roxane Laboratories:

Primary Outcome Measures:
  • bioequivalence determined by statistical comparison Cmax [ Time Frame: baseline, 2-period, 14 day washout ] [ Designated as safety issue: No ]

Enrollment: 37
Study Start Date: November 2005
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: mycophenolate mofetil
    mycophenolate mofetil 250 mg capsule
    Other Name: CellCept
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

  • Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to mycophenolate mofetil or any comparable or similar product.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00893919

Locations
United States, Texas
CEDRA Clinical Research, LLC
Austin, Texas, United States, 78759
Sponsors and Collaborators
Roxane Laboratories
Investigators
Principal Investigator: William Allen Alexander, M.D. CEDRA Clinical Research, LLC
  More Information

No publications provided

Responsible Party: Elizabeth Ernst, Director, Roxane Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00893919     History of Changes
Other Study ID Numbers: MYCO-C250-PVFD-1
Study First Received: May 4, 2009
Last Updated: October 9, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Mycophenolate mofetil
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
 Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013