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Sponsored by: |
Schering-Plough |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00653913 |
This study was designed to evaluate the pharmacokinetic interaction and safety of coadministration of SCH 58235 (ezetimibe) and pitavastatin in healthy Japanese adult male subjects or adult male subjects having no obvious disease other than high cholesterol levels.
Condition | Intervention | Phase |
---|---|---|
Hypercholesterolemia |
Drug: SCH 58235 Drug: pitavastatin |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study |
Official Title: | Evaluation of Potential for Pharmacokinetic Drug Interaction Between SCH 58235 and Pitavastatin |
Enrollment: | 18 |
Study Start Date: | March 2004 |
Study Completion Date: | September 2004 |
Primary Completion Date: | September 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Group A: Active Comparator
SCH 58235 (Period 1) Pitavastatin (Period 2) Coadministration (Period 3)
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Drug: SCH 58235
SCH 58235 10 mg (once daily)
Drug: pitavastatin
Pitavastatin 2 mg (once daily)
|
Group B: Active Comparator
SCH 58235 (Period 1) Coadministration (Period 2) Pitavastatin (Period 3)
|
Drug: SCH 58235
SCH 58235 10 mg (once daily)
Drug: pitavastatin
Pitavastatin 2 mg (once daily)
|
Group C: Active Comparator
Pitavastatin (Period 1) SCH 58235 (Period 2) Coadministration (Period 3)
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Drug: SCH 58235
SCH 58235 10 mg (once daily)
Drug: pitavastatin
Pitavastatin 2 mg (once daily)
|
Group D: Active Comparator
Pitavastatin (Period 1) Coadministration (Period 2) SCH 58235 (Period 3)
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Drug: SCH 58235
SCH 58235 10 mg (once daily)
Drug: pitavastatin
Pitavastatin 2 mg (once daily)
|
Group E: Active Comparator
Coadministration (Period 1) SCH 58235 (Period 2) Pitavastatin (Period 3)
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Drug: SCH 58235
SCH 58235 10 mg (once daily)
Drug: pitavastatin
Pitavastatin 2 mg (once daily)
|
Group F: Active Comparator
Coadministration (Period 1) Pitavastatin (Period 2) SCH 58235 (Period 3)
|
Drug: SCH 58235
SCH 58235 10 mg (once daily)
Drug: pitavastatin
Pitavastatin 2 mg (once daily)
|
Ages Eligible for Study: | 20 Years to 65 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Patients meeting any one of the following conditions are excluded from the study.
Responsible Party: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
Study ID Numbers: | P03962 |
Study First Received: | March 31, 2008 |
Last Updated: | April 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00653913 |
Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Metabolic Diseases Hyperlipidemias NK 104 Ezetimibe |
Metabolic disorder Hypercholesterolemia Dyslipidemias Lipid Metabolism Disorders |
Antimetabolites Molecular Mechanisms of Pharmacological Action Therapeutic Uses Antilipemic Agents |
Enzyme Inhibitors Anticholesteremic Agents Pharmacologic Actions |