Mycophenolate Mofetil Tablets Under Fasting Conditions

Study Overview
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Brief Summary
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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.

Detailed Description
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Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods

Official Title
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A Single-Dose, Replicate, Comparative Bioavailability Study of Two Formulations of Mycophenolate Mofetil 500 mg Tablets Under Fasting Conditions

Conditions
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Healthy

Intervention / Treatment
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* Drug: Mycophenolate Mofetil
* Drug: CellCept® Tablets


Participation Criteria
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Eligibility Criteria
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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: HIV. Hepatitis B surface antigen and Hepatitis C antibody. Using drugs of abuse test (marijuana, amphetamines, barbiturates, cocaine, opiates, benzodiazepines and methadone). Urine cotinine test 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: 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 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: Hypersensitivity or idiosyncratic reaction to mycophenolate mofetil and/or any other drug substances with similar activity. Alcoholism within the last 12 months. Drug dependence and/or substance abuse. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mycophenolate Mofetil (test) First<br>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<br>* Mycophenolate Mofetil Tablet 500 mg<br>|
| Active Comparator: Cellcept® (reference) First<br>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<br>* CellCept® Tablets, 500 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax - Maximum Observed Concentration | Bioequivalence based on Cmax | Blood samples collected over 72 hour period | 
| AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) | Bioequivalence based on AUC0-inf | Blood samples collected over 72 hour period | 
| AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) | Bioequivalence based on AUC0-t | Blood samples collected over 72 hour period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioequivalence, Subjects