Bioequivalency Study of Mycophenolate Mofetil 500 mg Tablets Under Fasted Conditions

Not Applicable

Completed

• Conditions: Prophylaxis of Organ Rejection

• Registration Number: NCT00894088
• Lead Sponsor: Roxane Laboratories

Brief Summary

The objective of this study was to prove the bioequivalence of Mycophenolate Mofetil 500 mg tablets under fasted conditions.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Primary Completion: 2006-01
• Study Completion: 2006-01
• Study First Submitted: 2009-05-04
• Study First Submitted QC: 2009-05-05
• Study First Posted: 2009-05-06
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-19
• Last Update Posted: 2018-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
bioequivalence determined by statistical comparison Cmax	baseline, 2-period, 14 day washout

Trial Locations

Locations (1)

CEDRA Clinical Research; 🇺🇸 Austin, Texas, United States