MD Ezetimibe Cyclosporine Interaction (0653-057)

Phase 1 Completed 13 enrolled Organon and Co Schering-Plough · collab

RandomizedCrossoverOpen-labelTreatment

Summary

Study to determine the effect of multiple oral doses of ezetimibe on the pharmacokinetics of a single oral dose cyclosporine in young healthy males and females.

Timeline

Start: 2003-11
Primary completion: 2004-01
Completion: 2004-01

Publications

Background Bergman AJ, Burke J, Larson P, Johnson-Levonas AO, Reyderman L, Statkevich P, Kosoglou T, Greenberg HE, Kraft WK, Frick G, Murphy G, Gottesdiener K, Paolini JF. Effects of ezetimibe on cyclosporine pharmacokinetics in healthy subjects. J Clin Pharmacol. 2006 Mar;46(3):321-7. doi: 10.1177/0091270005284851.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Cyclosporine	Peptide	100 mg	Oral
Comparator	Ezetimibe	Unknown	20 mg	Oral

Indications

No indication recorded.