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Sponsored by: |
Ernst Moritz Arndt University of Greifswald |
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Information provided by: | Ernst Moritz Arndt University of Greifswald |
ClinicalTrials.gov Identifier: | NCT00810303 |
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 |
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Pharmacokinetics Drug Interactions Pharmacodynamics Intestinal Transporter Expression |
Drug: 1 tablet Ezetrol(R) (ezetimibe), MSD Sharp & Dohme GmbH, Germany Drug: 1 tablet Ezetrol(R) + 2 capsules Sustiva(R) (efavirenz) single dose, DuPont Pharma Drug: tablet Ezetrol(R) and 2 capsules Sustiva(R) steady state |
Phase I |
Study Type: | Interventional |
Study Design: | Basic Science, Open Label, Active Control, Parallel Assignment, Pharmacokinetics/Dynamics Study |
Estimated Enrollment: | 12 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Active Comparator
administration of 1 tablet/day Ezetrol(R) (10 mg ezetimibe) on study day 1-9
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Drug: 1 tablet Ezetrol(R) (ezetimibe), MSD Sharp & Dohme GmbH, Germany
administration of 1 tablet/day Ezetrol(R) (10 mg ezetimibe)on study day 1-9
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B: Experimental
administration of 1 tablet/day Ezetrol(R) (10 mg ezetimibe) on study day 10-14 and 2 capsules Sustiva(R) (2x200 mg efavirenz) on study day 10
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Drug: 1 tablet Ezetrol(R) + 2 capsules Sustiva(R) (efavirenz) single dose, DuPont Pharma
administration of 1 tablet/day Ezetrol(R) (10 mg ezetimibe) on study say 10-14 and 2 capsules Sustiva(R) (2x200 mg efavirenz) on study day 10, 0-120 h blood sampling, 0-5 d urine sampling (24 h intervals) and 0-4 d feces sampling
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C: Experimental
administration of 1 tablet/day Ezetrol(R) (10 mg ezetimibe) and 2 capsules/day Sustiva(R) (2x200 mg efavirenz) on study day 15-28
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Drug: tablet Ezetrol(R) and 2 capsules Sustiva(R) steady state
administration of 1 tablet/day Ezetrol(R) (10 mg ezetimibe) and 2 capsules Sustiva(R) (2x200 mg efavirenz) on study day 15-28, 0-120 h blood sampling, urine sampling (24 h intervals) on study day 28 and feces sampling on study day 24-29
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Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
barbiturates, cimetidine, phenytoin, rifampicin)
Contact: Christiane Modeß, Dr | +49 (0)3834 865659 | chrimo@uni-greifswald.de |
Contact: Andrea Werzner | +49 (0)3834 865622 | werzner@uni-greifswald.de |
Germany | |
Department of Clinical Pharmacology | |
Greifswald, Germany, 17489 |
Principal Investigator: | Werner Siegmund, Prof | Department of Clinical Pharmacology |
Responsible Party: | Organization: Department of Clinical Pharmacology ( Prof. Dr. W. Siegmund, MD ) |
Study ID Numbers: | Efavirenz - 2008 |
Study First Received: | December 17, 2008 |
Last Updated: | December 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00810303 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Antimetabolites Efavirenz Anti-HIV Agents Anti-Retroviral Agents Antilipemic Agents |
Ezetimibe Anticholesteremic Agents Healthy Antiviral Agents Reverse Transcriptase Inhibitors |
Antimetabolites Efavirenz Anti-Infective Agents Anti-HIV Agents Molecular Mechanisms of Pharmacological Action Antilipemic Agents Ezetimibe Enzyme Inhibitors |
Anticholesteremic Agents Antiviral Agents Pharmacologic Actions Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Nucleic Acid Synthesis Inhibitors |