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Completed

NCT Number: NCT00893542

Bioequivalency Study of Mycophenolate Mofetil 250 mg Capsules Under Fasted Conditions

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

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Key information

Conditions

Prophylaxis of Organ Rejection

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CEDRA Clinical Research, LLC

Austin, Texas, 78759, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mycophenolate mofetil

Drug

mycophenolate mofetil 250 mg capsule

Other names: CellCept

Primary outcomes

  1. bioequivalence determined by statistical comparison Cmax

    Time frame: baseline, 2-period, 14 day washout

Sponsors and collaborators

Lead sponsor

Roxane Laboratories

Industry

Registry information

Official study title

A Single Dose, 2-Period, 2-Treatment 2-Way Crossover Bioequivalency Study of Mycophenolate Mofetil 250 mg Capsules Under Fasting Conditions

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
May 6, 2009
Registry last updated
Jan 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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