Overview

Mycophenolate Mofetil 250 mg Capsules Under Fed Conditions

Status:
Completed
Trial end date:
2006-11-01
Target enrollment:
0
Participant gender:
All
Summary
The objective of this study was to compare the oral availability of a test product of Mycophenolate Mofetil 250 mg capsule to an equivalent oral dose of the commercially available reference product, CellCeptĀ® 250 mg capsule administered to healthy subjects under fed conditions.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Teva Pharmaceuticals USA
Treatments:
Mycophenolate mofetil
Mycophenolic Acid
Criteria
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.