Status:
COMPLETED
Bioequivalency Study of Mycophenolate Mofetil 500 mg Tablets 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 500 mg tablets 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 :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2006
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00894088
Start Date
January 1 2006
End Date
January 1 2006
Last Update
January 23 2018
Active Locations (1)
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1
CEDRA Clinical Research
Austin, Texas, United States, 78759