Status:
COMPLETED
Pharmacokinetic and Pharmacodynamic Interactions Between the Cholesterol-lowering Ezetimibe and the Non-nucleoside Reverse Transcriptase Inhibitor Efavirenz During Chronic Treatment in Healthy Volunteers With Reference to Intestinal Expression of CYP3A4, UGT1A1, ABCB1 and ABCC2
Lead Sponsor:
University Medicine Greifswald
Conditions:
Pharmacokinetics
Drug Interactions
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the effects of a chronic co-medication of efavirenz on pharmacokinetics and sterol-lowering effects of ezetimibe at steady-state in healthy subjects genotyped ...
Eligibility Criteria
Inclusion
- age: 18 - 45 years
- sex: male and female
- ethnic origin: Caucasian
- body weight: 19 to 27 kg/m²
- good health as evidenced by the results of the clinical examination, ECG, and the laboratory check-up, which are judged by the clinical investigator not to differ in a clinical relevant way from the normal state
- written informed consent
Exclusion
- existing cardiac or haematological diseases and/or pathological findings, which might interfere with the drug's safety, tolerability, absorption and/or pharmacokinetics
- existing hepatic and renal diseases and/or pathological findings, which might interfere with the drug's safety, tolerability, absorption and/or pharmacokinetics
- existing gastrointestinal diseases and/or pathological findings, which might interfere with the drug's safety, tolerability, absorption and/or pharmacokinetics
- acute or chronic diseases which could affect drug absorption or metabolism
- history of any serious psychological disorder
- drug or alcohol dependence
- positive drug or alcohol screening
- smokers of 10 or more cigarettes per day
- positive anti-HIV-test, HBs-Ag-test or anti-HCV-test
- volunteers who are on a diet which could affect the pharmacokinetics of the drug
- heavy tea or coffee drinkers (more than 1L per day)
- lactation and pregnancy test positive or not performed
- volunteers suspected or known not to follow instructions
- volunteers who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to as a result of their participation in the study
- volunteers liable to orthostatic dysregulation, fainting, or blackouts
- blood donation or other blood loss of more than 400 ml within the last 12 weeks prior to the start of the study
- participation in a clinical trial during the last 3 months prior to the start of the study
- less than 14 days after last acute disease
- any systemically available medication within 4 weeks prior to the intended first administration unless because of the terminal elimination half-life complete elimination from the body can be assumed for the drug and/or its primary metabolites (except oral contraceptives)
- repeated use of drugs during the last 4 weeks prior to the intended first administration, which can influence hepatic biotransformation (e.g. barbiturates, cimetidine, phenytoin, rifampicin)
- repeated use of drugs during the last 2 weeks prior to the intended first administration which affect absorption (e.g. laxatives, metoclopramide, loperamide, antacids, H2-receptor antagonists)
- intake of grapefruit containing food or beverages within 7 days prior to administration
- known allergic reactions to the active ingredients used or to constituents of the pharmaceutical preparation
- subjects with severe allergies or multiple drug allergies
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00810303
Start Date
March 1 2009
End Date
July 1 2009
Last Update
October 11 2010
Active Locations (1)
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1
Department of Clinical Pharmacology
Greifswald, Germany, 17489