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Mycophenolate Mofetil Tablets Under Fed Conditions

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ClinicalTrials.gov Identifier: NCT00908128
Recruitment Status : Completed
First Posted : May 25, 2009
Results First Posted : July 21, 2009
Last Update Posted : August 20, 2009
Sponsor:
Information provided by:
Teva Pharmaceuticals USA

Tracking Information
First Submitted Date  ICMJE May 22, 2009
First Posted Date  ICMJE May 25, 2009
Results First Submitted Date  ICMJE June 12, 2009
Results First Posted Date  ICMJE July 21, 2009
Last Update Posted Date August 20, 2009
Study Start Date  ICMJE August 2006
Actual Primary Completion Date August 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2009)
  • Cmax - Maximum Observed Concentration [ Time Frame: Blood samples collected over 72 hour period ]
  • AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) [ Time Frame: Blood samples collected over 72 hour period ]
  • AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of the Last Non-zero Concentration [ Time Frame: Blood samples collected over 72 hour period ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 22, 2009)
  • Bioequivalence Based on Cmax [ Time Frame: Blood samples collected over 72 hour period ]
  • Bioequivalence Based on AUC0-Inf [ Time Frame: Blood samples collected over 72 hour period ]
  • Bioequivalence Based on AUC0-t [ Time Frame: Blood samples collected over 72 hour period ]
Change History Complete list of historical versions of study NCT00908128 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mycophenolate Mofetil Tablets Under Fed Conditions
Official Title  ICMJE A Single-Dose, Replicate, Comparative Bioavailability Study of Two Formulations of Mycophenolate Mofetil 500 mg Tablets Under Fed Conditions
Brief Summary 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 fed conditions.
Detailed Description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Mycophenolate Mofetil
    Mycophenolate Mofetil 500 mg Tablet
  • Drug: CellCept®
    CellCept® Tablets, 500 mg
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Mycophenolate Mofetil
  • 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.
    Intervention: Drug: CellCept®
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 22, 2009)
40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2006
Actual Primary Completion Date August 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00908128
Other Study ID Numbers  ICMJE 2006-1264
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Teva Pharmaceuticals USA
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Xueyu (Eric) Chen, MD, PhD., FRCP(C) Pharma Medica Research, Inc.
PRS Account Teva Pharmaceuticals USA
Verification Date August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP