Trials Sponsors Conditions Drugs Pricing

Conditions

Drug Interactions Hypercholesterolemia Immunosuppression Pharmacokinetics

Keywords

pharmacokineticsdrug interactionsezetimibesirolimushuman experimentation

Outcome Measures

Primary Outcomes (1)

Primary characteristics: for ezetimibe: AUC0-∞, Cmax; for sirolimus: AUC0-∞, Cmax
April 2007 to June 2007

Secondary Outcomes (1)

Second. characteristics: for ezetimibe: CLR, Ae (urine), Ae (feces); for ezetimibe glucuronide: AUC0-∞, Cmax, Ae (urine), Ae (feces); for ezetimibe, ezetimibe glucuronide and sirolimus: AUC0-t, t½, tmax
April 2007 to June 2007

Study Arms (3)

A

ACTIVE COMPARATOR

administration of 1 tablet Ezetrol(R) (10 mg ezetimibe)

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

B

ACTIVE COMPARATOR

administration of 5 ml Rapamune(R) oral solution (1 mg/ml sirolimus)

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

C

EXPERIMENTAL

administration of 1 tablet Ezetrol(R) (10 mg ezetimibe) and 5 ml Rapamune(R) oral solution (1 mg/ml sirolimus)

Interventions

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

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

Also known as: Ezetrol

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

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

Eligibility Criteria

Age18 Years - 45 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

age: 18 - 45 years
sex: male and female

Sponsors & Collaborators

University Medicine Greifswald
Otherlead

Study Sites (1)

Department of Clinical Pharmacology

Greifswald, 17487, Germany

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

EzetimibeSirolimus

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

AzetidinesAzetinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMacrolides

Study Officials

Werner Siegmund, Prof
Department of Clinical Pharmacology
PRINCIPAL INVESTIGATOR

Enrollment

24 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: NONE
Purpose: BASIC SCIENCE
Intervention Model: CROSSOVER
Sponsor Type: OTHER

Study Record Dates

First Submitted

February 12, 2008

First Posted

February 22, 2008

Study Start

April 2007

Date type not reported

This date has not been verified as actual or estimated.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (3)

A

B

C

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (3)

A

B

C

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations