Mycophenolate Mofetil Tablets Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00907907
First received: May 22, 2009
Last updated: August 14, 2009
Last verified: August 2009
  Purpose

The objective of this study was to evaluate the comparative bioavailability between Mycophenolate Mofetil 500 mg Tablets (test) and CellCept® 500 mg tablets (reference), after a single-dose in healthy subjects under fasting conditions.


Condition Intervention Phase
Healthy
Drug: Mycophenolate Mofetil
Drug: CellCept® Tablets
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Single-Dose, Replicate, Comparative Bioavailability Study of Two Formulations of Mycophenolate Mofetil 500 mg Tablets Under Fasting Conditions

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceuticals USA:

Primary Outcome Measures:
  • Cmax - Maximum Observed Concentration [ Time Frame: Blood samples collected over 72 hour period ] [ Designated as safety issue: No ]
  • AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) [ Time Frame: Blood samples collected over 72 hour period ] [ Designated as safety issue: No ]
  • AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) [ Time Frame: Blood samples collected over 72 hour period ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: July 2006
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mycophenolate Mofetil (test) First
Mycophenolate Mofetil Tablets, 500 mg dosed in first period followed by CellCept® Tablets, 500 mg dosed in second period; sequence repeated in third and fourth periods.
Drug: Mycophenolate Mofetil
Mycophenolate Mofetil Tablet 500 mg
Active Comparator: Cellcept® (reference) First
CellCept® Tablets, 500 mg dosed in first period followed by Mycophenolate Mofetil Tablets, 500 mg dosed in second period; sequence repeated in third and fourth periods.
Drug: CellCept® Tablets
CellCept® Tablets, 500 mg

Detailed Description:

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy, non-smoking male subjects, 18 years of age or older.
  • Healthy, non-smoking post-menopausal or surgically sterile females 18 years of age or older.
  • BMI ≥ 19 and ≤ 30.
  • Negative for:

    1. HIV.
    2. Hepatitis B surface antigen and Hepatitis C antibody.
    3. Using drugs of abuse test (marijuana, amphetamines, barbiturates, cocaine, opiates, benzodiazepines and methadone).
    4. Urine cotinine test
    5. Serum HCG consistent with pregnancy (females only)
  • No significant diseases or clinically significant findings in a physical examination.
  • No clinically significant abnormal laboratory values.
  • No clinically significant findings in vital signs measurements and a 12-lead electrocardiogram (ECG).
  • Be informed of the nature of the study and given written consent prior to receiving any study procedure.
  • Females who participate in this study must be unable to have children:

    1. post-menopausal for at least 1 year - no menstrual cycle for 12 months and LH and FSH levels judged by a physician to be consistent with post-menopausal status.

      OR

    2. Proof of surgical sterility.
  • Females who participate in this study are not pregnant and/or non-lactating.

Exclusion Criteria:

  • Known history or presence of any clinically significant medical condition.
  • Known or suspected carcinoma.
  • Known or suspected increased susceptibility to infection.
  • Known history or presence of active tuberculosis (TB).
  • Results of a previous TB skin test greater than 5 mm in diameter.
  • Lived in or traveled, during the last 8 weeks, to a country defined by the Public Health Agency of Canada as having WHO estimated sputum smear positive pulmonary TB rate of 15 per 100,000 or higher.
  • Known history or presence of:

    1. Hypersensitivity or idiosyncratic reaction to mycophenolate mofetil and/or any other drug substances with similar activity.
    2. Alcoholism within the last 12 months.
    3. Drug dependence and/or substance abuse.
    4. Use of tobacco or nicotine-containing products within the last 6 months.
  • On a special diet within 4 weeks prior to drug administration (e.g. liquid, protein, raw food diet).
  • Participated in another clinical trial or received and investigational product within 30 days prior to drug administration.
  • Donated up to 250 mL of blood within the previous 30 days OR Donated from 251 to 499 mL of blood in the previous 45 days OR Donated more than 499 mL of blood in the previous 56 days (based on the Canadian Blood Services guideline for blood donation.
  • Females taking oral or transdermal hormonal contraceptives within 14 days preceding period 1 dosing.
  • Females having taken implanted or injected hormonal contraceptives within 6 months prior to period 1 dosing.
  • Requirement of any non-topical medication (prescription and/or over-the-counter) on a routine basis.
  • Difficulty fasting or consuming the standard meals.
  • Do not tolerate venipuncture.
  • Unable to read or sign the ICF.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00907907

Locations
Canada, Ontario
Pharma Medica Research Inc.
Toronto, Ontario, Canada, M1R 5A3
Sponsors and Collaborators
Teva Pharmaceuticals USA
Investigators
Principal Investigator: Xueyu (Eric) Chen, MD, Ph.D., FRCP(C) Pharma Medica Research Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00907907     History of Changes
Other Study ID Numbers: 2006-1263
Study First Received: May 22, 2009
Results First Received: June 12, 2009
Last Updated: August 14, 2009
Health Authority: Canada: Ethics Review Committee

Keywords provided by Teva Pharmaceuticals USA:
Bioequivalence
Subjects

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 April 17, 2014