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Bioequivalency Study of Mycophenolate Mofetil 250 mg Capsules Under Fasted Conditions

This study has been completed.
Sponsor:
Information provided by:
Roxane Laboratories
ClinicalTrials.gov Identifier:
NCT00893542
First received: May 4, 2009
Last updated: October 9, 2009
Last verified: October 2009
May 4, 2009
October 9, 2009
November 2005
November 2005   (Final data collection date for primary outcome measure)
bioequivalence determined by statistical comparison Cmax [ Time Frame: baseline, 2-period, 14 day washout ]
Same as current
Complete list of historical versions of study NCT00893542 on ClinicalTrials.gov Archive Site
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Bioequivalency Study of Mycophenolate Mofetil 250 mg Capsules Under Fasted Conditions
A Single Dose, 2-Period, 2-Treatment 2-Way Crossover Bioequivalency Study of Mycophenolate Mofetil 250 mg Capsules Under Fasting Conditions
The objective of this study was to prove the bioequivalence of Mycophenolate Mofetil 250 mg Capsules under fasted conditions.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Prophylaxis of Organ Rejection
Drug: Mycophenolate Mofetil
mycophenolate mofetil 250 mg capsule
Other Name: CellCept
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
November 2005
November 2005   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00893542
MYCO-C250-PVFS-1
No
Not Provided
Not Provided
Elizabeth Ernst, Director, Roxane Laboratories, Inc.
Roxane Laboratories
Not Provided
Principal Investigator: William Allen Alexander, M.D. CEDRA Clinical Research, LLC
Roxane Laboratories
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP