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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: | NCT00621101 |
The purpose of this study is to confirm a significant influence of ezetimibe and sirolimus on each others pharmacokinetics
Condition | Intervention | Phase |
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Pharmacokinetics Drug Interactions Hypercholesterolemia Immunosuppression |
Drug: 1 tablet Ezetrol(R) (ezetimibe), MSD Sharp & Dohme GmbH, Germany Drug: 1 tablet Rapamune(R) (sirolimus), Wyeth Pharma, Germany Drug: 1 tablet Ezetrol(R) + 1 tablet Rapamune(R) |
Phase I |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study |
Official Title: | Pharmacokinetic Drug Interaction Between Ezetimibe and Sirolimus After Single Dose Administration in Healthy Subjects |
Enrollment: | 24 |
Study Start Date: | April 2007 |
Study Completion Date: | June 2007 |
Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Active Comparator
administration of 1 tablet Ezetrol(R) (10 mg ezetimibe)
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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
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B: Active Comparator
administration of 5 ml Rapamune(R) oral solution (1 mg/ml sirolimus)
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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
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C: Experimental
administration of 1 tablet Ezetrol(R) (10 mg ezetimibe) and 5 ml Rapamune(R) oral solution (1 mg/ml sirolimus)
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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
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Hypercholesterolemia is a frequent finding in organ transplant recipients receiving immunosuppressive drugs such as sirolimus. To prevent increased cardiovascular morbidity and mortality in these patients, co-medication with lipid-lowering statins is recommended. However, treatment with statins is limited in many patients by insufficient cholesterol-lowering efficacy, drug interactions and serious adverse drug reactions (e.g. rhabdomyolysis). These patients may benefit from comedication with the cholesterol absorption inhibitor ezetimibe (EZE). Since SIR and EZE were shown to be substrates of the efflux transporter ABCB1 (P-glycoprotein), drug interactions between both compounds may occur. Therefore, this clinical study in healthy subjects was initiated to evaluate the clinical relevance of drug/drug interactions between sirolimus and ezetimibe according to the accepted bioequivalence approach.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Germany | |
Department of Clinical Pharmacology | |
Greifswald, Germany, 17487 |
Principal Investigator: | Werner Siegmund, Prof | Department of Clinical Pharmacology |
Responsible Party: | Department of Clinical Pharmacology ( Prof. Dr. W. Siegmund, MD ) |
Study ID Numbers: | Eze-Siro, EudraCT-No. 2006-006597-18 |
Study First Received: | February 12, 2008 |
Last Updated: | February 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00621101 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
pharmacokinetics drug interactions ezetimibe sirolimus human experimentation |
Sirolimus Metabolic Diseases Hyperlipidemias Clotrimazole Miconazole Tioconazole |
Ezetimibe Healthy Metabolic disorder Hypercholesterolemia Dyslipidemias Lipid Metabolism Disorders |
Antimetabolites Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Antilipemic Agents Physiological Effects of Drugs |
Anticholesteremic Agents Antibiotics, Antineoplastic Immunosuppressive Agents Pharmacologic Actions Anti-Bacterial Agents Therapeutic Uses Antifungal Agents |