Bioequivalency Study of Mycophenolate Mofetil 500 mg Tablets Under Fed Conditions

Roxane Laboratories39 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prophylaxis of Organ Rejection

Interventions

Mycophenolate MofetilDRUG

Prophylaxis of Organ Rejection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

CEDRA Clinical Research

Austin, Texas, United States

Outcomes

Primary Outcomes

bioequivalence determined by statistical comparison Cmax

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

Data from ClinicalTrials.gov

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