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| Sponsor: | University Medicine Greifswald |
|---|---|
| Information provided by: | University Medicine Greifswald |
| ClinicalTrials.gov Identifier: | NCT00810303 |
Purpose
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 for ABCB1, ABCC2, CYP2B6 and UGT1A1.
| Condition | Intervention | Phase |
|---|---|---|
|
Pharmacokinetics Drug Interactions Pharmacodynamics Intestinal Transporter Expression |
Drug: Ezetrol (ezetimibe) multiple dose Drug: Ezetrol (ezetimibe) multiple dose and Sustiva (efavirenz) single dose Drug: Ezetrol (ezetimibe) and Sustiva (efavirenz) multiple dose Drug: Sustiva (efavirenz) single dose |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
| Enrollment: | 12 |
| Study Start Date: | March 2009 |
| Study Completion Date: | July 2009 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: whole study group
A study with a duration of 34 days with 4 periods (= 4 pharmakokinetics) on 12 healthy subjects.
|
Drug: Ezetrol (ezetimibe) multiple dose
administration of 1 tablet/day Ezetrol (10 mg ezetimibe) on study day 6-15 and a pharmakokinetic on study day 15 (0-24 h blood sampling, 0-24 h urine sampling and 5 d feces sampling (study day 11-15))
Other Name: Ezetrol
Drug: Ezetrol (ezetimibe) multiple dose and Sustiva (efavirenz) single dose
administration of 1 tablet/day Ezetrol(R) (10 mg ezetimibe) on study day 16-20 and 2 capsules Sustiva(R) (2x200 mg efavirenz) on study day 16 with a pharmakokinetic (0-120 h blood sampling, urine sampling (24 h intervals) and feces sampling on study days 16-20)
Other Name: Ezetrol+Sustiva single dose
Drug: Ezetrol (ezetimibe) and Sustiva (efavirenz) multiple dose
administration of 1 tablet/day Ezetrol(R) (10 mg ezetimibe) and 2 capsules/day Sustiva(R) (2x200 mg efavirenz) on study day 21-30 and with a pharmakokinetic (0-120 h blood sampling, urine sampling (24 h intervals) on study day 30 and feces sampling on study day 26-30)
Other Name: Ezetrol+Sustiva steady state
Drug: Sustiva (efavirenz) single dose
administration of 2 capsules Sustiva(R) (2x200 mg efavirenz) on study day 1 with a pharmakokinetic (0-120 h blood sampling, urine sampling (24 h intervals) and feces sampling on study days 1-5)
Other Name: Sustiva
|
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Germany | |
| Department of Clinical Pharmacology | |
| Greifswald, Germany, 17489 | |
| Principal Investigator: | Werner Siegmund, Prof | Department of Clinical Pharmacology |
More Information
| Responsible Party: | Prof. Dr. W. Siegmund, MD, Organization: Department of Clinical Pharmacology |
| ClinicalTrials.gov Identifier: | NCT00810303 History of Changes |
| Other Study ID Numbers: | Efavirenz - 2008 |
| Study First Received: | December 17, 2008 |
| Results First Received: | June 21, 2010 |
| Last Updated: | September 23, 2010 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
Reverse Transcriptase Inhibitors Efavirenz Ezetimibe Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Retroviral Agents |
Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Lipid Regulating Agents |