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

Phase 1 Completed 32 enrolled Hoffmann-La Roche

RandomizedCrossoverOpen-labelTreatment

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.

Timeline

Start: 2008-07
Primary completion: 2008-10
Completion: 2008-10

Publications

Reigner B, Grange S, Bentley D, Banken L, Abt M, Hughes R, Scheubel E, Guentert TW. Generics in transplantation medicine: Randomized comparison of innovator and substitution products containing mycophenolate mofetil . Int J Clin Pharmacol Ther. 2019 Oct;57(10):506-519. doi: 10.5414/CP203487.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mycophenolate Mofetil	Small molecule	500 mg	Oral

Indications

No indication recorded.