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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: | NCT00621699 |
The purpose of this study is to confirm a significant influence of ezetimibe and tacrolimus on each others pharmacokinetics
Condition | Intervention | Phase |
---|---|---|
Pharmacokinetics Drug Interactions Hypercholesterolemia Immunosuppression |
Drug: 1 tablet Ezetrol(R) (ezetimibe), MSD Sharp & Dohme GmbH, Germany Drug: 1 capsule Prograf(R) (tacrolimus), Astellas Pharma GmbH, Germany Drug: 1 tablet Ezetrol(R) + 1 capsules Prograf(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 Tacrolimus After Single Dose Administration in Healthy Subjects |
Enrollment: | 24 |
Study Start Date: | September 2007 |
Study Completion Date: | November 2007 |
Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
C: Experimental
administration of 1 tablet Ezetrol(R) (10 mg ezetimibe) and 1 capsule Prograf(R) (5 mg tacrolimus)
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Drug: 1 tablet Ezetrol(R) + 1 capsules Prograf(R)
administration of 1 tablet Ezetrol(R) (10 mg ezetimibe) and 1 capsule Prograf(R) (5 mg Tacrolimus), 0-144 h blood sampling, 0-5 d urine sampling (24 h intervals) and 0-10 d feces sampling
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A: Active Comparator
administration of 1 tablet Ezetrol(R) (10 mg ezetimibe)
|
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
|
B: Active Comparator
administration of 1 capsule Prograf(R) (5 mg tacrolimus)
|
Drug: 1 capsule Prograf(R) (tacrolimus), Astellas Pharma GmbH, Germany
administration of 1 capsule Prograf(R) (5 mg tacrolimus), 0-144 h blood sampling
|
Hypercholesterolemia is a frequent finding in organ transplant recipients receiving immunosuppressive drugs such as tacrolimus. 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. Since tacrolimus and ezetimibe 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 tacrolimus 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-Tacro, 2006-006549-14 |
Study First Received: | February 12, 2008 |
Last Updated: | February 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00621699 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
pharmacokinetics drug interactions ezetimibe tacrolimus human experimentation |
Antimetabolites Hyperlipidemias Metabolic Diseases Immunologic Factors Antilipemic Agents Ezetimibe Healthy |
Tacrolimus Anticholesteremic Agents Immunosuppressive Agents Hypercholesterolemia Metabolic Disorder Dyslipidemias Lipid Metabolism Disorders |
Antimetabolites Hyperlipidemias Metabolic Diseases Molecular Mechanisms of Pharmacological Action Immunologic Factors Antilipemic Agents Physiological Effects of Drugs Ezetimibe |
Tacrolimus Anticholesteremic Agents Immunosuppressive Agents Pharmacologic Actions Therapeutic Uses Hypercholesterolemia Dyslipidemias Lipid Metabolism Disorders |