Overview

Bioequivalency Study of Mycophenolate Mofetil 250 mg Capsules Under Fed Conditions

Status:
Completed
Trial end date:
2005-11-01
Target enrollment:
0
Participant gender:
All
Summary
The objective of this study was to prove the bioequivalence of Mycophenolate Mofetil 250 mg Capsules under fed conditions.
Phase:
N/A
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Roxane Laboratories
Treatments:
Mycophenolate mofetil
Mycophenolic Acid
Criteria
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.