Mycophenolate Mofetil 250 mg Capsules Under Fasting Conditions

Study Overview
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Brief Summary
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The objective of this study was to compare the oral bioavailability of an investigational formulation of mycophenolate mofetil (MMF) 250 mg capsules to an equivalent dose of the commercially available reference product, CellCept® (mycophenolate mofetil) 250 mg administered to healthy subjects following an overnight fast of at least 10 hours.

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, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalence Study of Mycophenolate Mofetil 250 mg Capsules Under Fasting Conditions

Conditions
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Healthy

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All subjects must satisfy the following criteria to be considered for study participation: Subject must be male or non-pregnant, non-breast-feeding female Subject must be at least 18 years of age Subject must have a Body Mass Index (BMI) between 19 and 30 kg/m2, inclusive, and body weight should be at least 50 kg (110 lbs) Female Subjects - not surgically sterile or at least two years postmenopausal - must agree to utilize one of the following forms of contraception, if sexually active with a male partner, from screening through completion of the study. Approved forms of contraception are abstinence, double barrier (condom with spermicide, diaphragm with spermicide), intra-uterine device (IUD), or vasectomized partner (6 months minimum since vasectomy). Subject must voluntarily consent to participate in this study and provide their written informed consent prior to the start of any study-specific procedures. Subject is willing and able to remain in the study unit for the entire duration of each confinement period and return for any outpatient visits. Exclusion Criteria: Subjects may be excluded for any of the following: History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease or any other condition which, in the opinion of the Investigator would jeopardize the safety of the subject or the validity of the study results. Has a clinically significant abnormal finding on the physical exam, medical history, ECG or clinical laboratory results at screening. History or presence of allergic or adverse response to mycophenolate mofetil or related drugs. Has been on a significantly abnormal diet during the four weeks preceding the first dose of study medication. Has donated blood or plasma within 30 days prior to the first dose of study medication. Has participated in another clinical trial within 30 days prior to the first dose of study medication. Has used any over-the-counter (OTC) medication, including nutritional supplements, within 7 days prior to the first dose of study medication. Has used any prescription medication, including hormonal contraceptive or hormonal replacement therapy, within 14 days prior to the first dose of study medication. Has been treated with any known enzyme altering drugs such as barbiturates, phenothiazines, cimetidine, carbamazepine, etc., within 30 days prior to the first dose of study medication. Has smoked or used tobacco products within 90 days prior to the first dose of study medication. Is a female with a positive pregnancy test result. Female who has used implanted hormonal contraceptives anytime during the 6 months prior to study start. Has an intolerance to venipuncture. Has difficulty fasting or consuming standard meals. Has a positive urine screen for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine, cannabinoids, opiates) Has a history of drug or alcohol abuse. Has had a positive test for, or has been treated for hepatitis B, hepatitis C or HIV.

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: Test (mycophenolate mofetil) First<br>Mycophenolate Mofetil 250 mg Capsule dosed in first period followed by CellCept® 250 mg Capsule dosed in second period. | Drug: Mycophenolate Mofetil<br>* 250 mg Capsule<br>|
| Active Comparator: Reference (CellCept®) First<br>CellCept® 250 mg Capsule dosed in first period followed by Mycophenolate Mofetil 250 mg Capsule dosed in second period. | Drug: CellCept®<br>* 250 mg Capsule<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 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 Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration | 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, Healthy Subjects