Pharmacokinetic Drug Interaction Between Ezetimibe and Sirolimus After Single Dose Administration in Healthy Subjects

PHASE1CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

April 30, 2007

Primary Completion Date

June 30, 2007

Study Completion Date

June 30, 2007

Conditions
PharmacokineticsDrug InteractionsHypercholesterolemiaImmunosuppression
Interventions
DRUG

1 tablet Ezetrol(R) (ezetimibe), MSD Sharp & Dohme GmbH, Germany

administration of 1 tablet Ezetrol(R) (10 mg ezetimibe), 0-144 h blood sampling, 0-5 d urine sampling (24 h intervals) and 0-10 d feces sampling

DRUG

1 tablet Rapamune(R) (sirolimus), Wyeth Pharma, Germany

administration of 5 ml Rapamune(R) oral solution (1 mg/ml sirolimus), 0-144 h blood sampling

DRUG

1 tablet Ezetrol(R) + 1 tablet Rapamune(R)

administration of 1 tablet Ezetrol(R) (10 mg ezetimibe) and 5 ml Rapamune(R) oral solution (1 mg/ml sirolimus), 0-144 h blood sampling, 0-5 d urine sampling (24 h intervals) and 0-10 d feces sampling

Trial Locations (1)

17487

Department of Clinical Pharmacology, Greifswald

All Listed Sponsors
lead

University Medicine Greifswald

OTHER

NCT00621101 - Pharmacokinetic Drug Interaction Between Ezetimibe and Sirolimus After Single Dose Administration in Healthy Subjects | Biotech Hunter | Biotech Hunter