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Study to Compare the Pharmacokinetics of Mycophenolate Mofetil Metabolites From Four Tablet Formulations in Healthy Participants

NCT02981290 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2016-12-05

No results posted yet for this study

Summary

This is a single center, randomized, open label, 4-treatment, 4-period, 4-sequence, 4-way crossover study to compare the pharmacokinetics of mycophenolate mofetil (MMF) metabolites from 4 tablet formulations in healthy participants.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Renodapt

Renodapt will be administered as 500 milligrams (mg) tablet orally on Day 1 in any treatment periods.

DRUG

Mycept

Mycept will be administered as 500 mg tablet orally on Day 1 in any treatment periods.

DRUG

Cellmune

Cellmune will be administered as 500 mg tablet orally on Day 1 in any treatment periods.

DRUG

CellCept

CellCept will be administered as 500 mg tablet orally on Day 1 in any treatment periods.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2008-10-31
Completion
2008-10-31

Countries

  • New Zealand

Study Locations

More Related Trials

Entities

Companies

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 NCT02981290 on ClinicalTrials.gov