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

NCT00621101 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2008-02-22

No results posted yet for this study

Summary

The purpose of this study is to confirm a significant influence of ezetimibe and sirolimus on each others pharmacokinetics

Conditions

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

Sponsors & Collaborators

  • University Medicine Greifswald

    lead OTHER

Principal Investigators

  • Werner Siegmund, Prof · Department of Clinical Pharmacology

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2007-06-30
Completion
2007-06-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

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 NCT00621101 on ClinicalTrials.gov