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Mycophenolate Mofetil 250 mg Capsules Under Fasting Conditions

NCT00911274 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2024-08-19

Study results available
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Summary

The objective of this study was to compare the oral bioavailability of an investigational formulation of mycophenolate mofetil (MMF) 250 mg capsules to an equivalent dose of the commercially available reference product, CellCept® (mycophenolate mofetil) 250 mg administered to healthy subjects following an overnight fast of at least 10 hours.

Conditions

  • Healthy

Interventions

DRUG

Mycophenolate Mofetil

250 mg Capsule

DRUG

CellCept®

250 mg Capsule

Sponsors & Collaborators

  • Teva Pharmaceuticals USA

    lead INDUSTRY

Principal Investigators

  • Frederick A Bieberdorf, MD · Cedra Clinical Research, LLC

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2006-11-30
Completion
2006-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00911274 on ClinicalTrials.gov