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Bioequivalency Study of Mycophenolate Mofetil 250 mg Capsules Under Fasted Conditions

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ClinicalTrials.gov Identifier: NCT00893542
Recruitment Status : Completed
First Posted : May 6, 2009
Last Update Posted : January 23, 2018
Sponsor:
Information provided by:
West-Ward Pharmaceutical

Brief Summary:
The objective of this study was to prove the bioequivalence of Mycophenolate Mofetil 250 mg Capsules under fasted conditions.

Condition or disease Intervention/treatment Phase
Prophylaxis of Organ Rejection Drug: Mycophenolate Mofetil Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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 Fasting Conditions
Study Start Date : November 2005
Actual Primary Completion Date : November 2005
Actual Study Completion Date : November 2005



Intervention Details:
    Drug: Mycophenolate Mofetil
    mycophenolate mofetil 250 mg capsule
    Other Name: CellCept


Primary Outcome Measures :
  1. bioequivalence determined by statistical comparison Cmax [ Time Frame: baseline, 2-period, 14 day washout ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00893542


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

Responsible Party: Elizabeth Ernst, Director, Roxane Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00893542     History of Changes
Other Study ID Numbers: MYCO-C250-PVFS-1
First Posted: May 6, 2009    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action