Bioequivalency Study of Mycophenolate Mofetil 250 mg Capsules Under Fasted Conditions

This study has been completed.

First Received: May 4, 2009 Last Updated: May 5, 2009 History of Changes

Sponsored by:	Roxane Laboratories
Information provided by:	Roxane Laboratories
ClinicalTrials.gov Identifier:	NCT00893542

Purpose

The objective of this study was to prove the bioequivalence of Mycophenolate Mofetil 250 mg Capsules under fasted conditions.

Condition	Intervention
Prophylaxis of Organ Rejection	Drug: Mycophenolate Mofetil

Drug Information available for: Mycophenolate mofetil hydrochloride Mycophenolate Mofetil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study
Official Title:	A Single Dose, 2-Period, 2-Treatment 2-Way Crossover Bioequivalency Study of Mycophenolate Mofetil 250 mg Capsules Under Fasting Conditions

Further study details as provided by Roxane Laboratories:

Primary Outcome Measures:

bioequivalence determined by statistical comparison Cmax [ Time Frame: baseline, 2-period, 14 day washout ] [ Designated as safety issue: No ]

Enrollment:	37
Study Start Date:	November 2005
Study Completion Date:	November 2005
Primary Completion Date:	November 2005 (Final data collection date for primary outcome measure)

Intervention Details:

mycophenolate mofetil 250 mg capsule

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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 Protriptyline or any comparable or similar product.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00893542

Locations

United States, Texas
CEDRA Clinical Research, LLC
Austin, Texas, United States, 78759

Sponsors and Collaborators

Roxane Laboratories

Investigators

Principal Investigator:

William Allen Alexander, M.D.

CEDRA Clinical Research, LLC

More Information

No publications provided

Responsible Party:	Roxane Laboratories, Inc. ( Elizabeth Ernst, Director )
Study ID Numbers:	MYCO-C250-PVFS-1
Study First Received:	May 4, 2009
Last Updated:	May 5, 2009
ClinicalTrials.gov Identifier:	NCT00893542 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Anti-Bacterial Agents
Immunologic Factors
Mycophenolic Acid
Mycophenolate mofetil
Immunosuppressive Agents

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Mycophenolic Acid

Mycophenolate mofetil
Enzyme Inhibitors
Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009