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Bioequivalency Study of Mycophenolate Mofetil 500 mg Tablets Under Fed Conditions

NCT ID: NCT00893958

Last Updated: 2018-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2006-01-31

Brief Summary

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

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Detailed Description

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Conditions

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Prophylaxis of Organ Rejection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Mycophenolate Mofetil

Prophylaxis of Organ Rejection

Intervention Type DRUG

Other Intervention Names

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CellCept

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Roxane Laboratories

INDUSTRY

Sponsor Role lead

Responsible Party

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Roxane Laboratories, Inc.

Principal Investigators

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William Allan Alexander, M.D.

Role: PRINCIPAL_INVESTIGATOR

CEDRA Clinical Research

Locations

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CEDRA Clinical Research

Austin, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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MYCO-T500-PVFD-1

Identifier Type: -

Identifier Source: org_study_id

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