NCT00893919CompletedNot Applicable
A Single Dose, 2-Period, 2-Treatment 2-Way Crossover Bioequivalency Study of Mycophenolate Mofetil 250 mg Capsules Under Fed Conditions
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Roxane Laboratories
- Enrollment
- 37
- Locations
- 1
- Primary Endpoint
- bioequivalence determined by statistical comparison Cmax
Study Overview
Brief Summary
The objective of this study was to prove the bioequivalence of Mycophenolate Mofetil 250 mg Capsules under fed conditions.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening
Exclusion Criteria
- •Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to mycophenolate mofetil or any comparable or similar product.
Outcomes
Primary Outcomes
bioequivalence determined by statistical comparison Cmax
Time Frame: baseline, 2-period, 14 day washout
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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