Status:
COMPLETED
Bioequivalency Study of Mycophenolate Mofetil 250 mg Capsules Under Fasted Conditions
Lead Sponsor:
Roxane Laboratories
Conditions:
Prophylaxis of Organ Rejection
Eligibility:
All Genders
18-45 years
Phase:
NA
Brief Summary
The objective of this study was to prove the bioequivalence of Mycophenolate Mofetil 250 mg Capsules under fasted conditions.
Eligibility Criteria
Inclusion
- No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2005
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00893542
Start Date
November 1 2005
End Date
November 1 2005
Last Update
January 23 2018
Active Locations (1)
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1
CEDRA Clinical Research, LLC
Austin, Texas, United States, 78759