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Sponsors and Collaborators: |
Merck Schering-Plough |
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Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00653276 |
Study to determine the effect of multiple oral doses of ezetimibe on the pharmacokinetics of a single oral dose cyclosporine in young healthy males and females.
Condition | Intervention | Phase |
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Cholesterol |
Drug: ezetimibe Drug: Comparator: cyclosporine |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study |
Official Title: | An Open-Label, 2-Period, Crossover Study to Determine the Effect of Multiple Oral Doses of Ezetimibe 20 mg on the Pharmacokinetics of a Single Oral Dose of Cyclosporine in Young, Healthy, Normal, Male and Female Subjects |
Enrollment: | 13 |
Study Start Date: | November 2003 |
Primary Completion Date: | January 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Treatment A: Active Comparator
Treatment A: subjects will be given a single oral dose of cyclosporine 100 mg capsules on Day 1.
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Drug: Comparator: cyclosporine
single oral dose of cyclosporine 100 mg capsules on Day 1 or Day 7.
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Treatment B: Active Comparator
Treatment B: subjects will receive single oral daily doses of ezetimibe 20 mg (2 x 10 mg tablets) on Days 1 through 6, followed by coadministration of a single oral dose of ezetimibe 20 mg (2 x 10 mg tablets) and cyclosporine 100 mg capsule on Day 7.
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Drug: ezetimibe
ezetimibe 20 mg (2 x 10 mg tablets) on Days 1 through Day 7.
Drug: Comparator: cyclosporine
single oral dose of cyclosporine 100 mg capsules on Day 1 or Day 7.
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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:
Responsible Party: | Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences ) |
Study ID Numbers: | 2008_520, MK0653-057 |
Study First Received: | April 1, 2008 |
Last Updated: | April 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00653276 |
Health Authority: | United States: Food and Drug Administration |
Cyclosporine Clotrimazole Miconazole Tioconazole |
Ezetimibe Healthy Cyclosporins |
Antimetabolites Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Immunologic Factors Antilipemic Agents Physiological Effects of Drugs Enzyme Inhibitors |
Anticholesteremic Agents Immunosuppressive Agents Pharmacologic Actions Antifungal Agents Therapeutic Uses Antirheumatic Agents Dermatologic Agents |