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Sponsored by: |
Genzyme |
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Information provided by: | Genzyme |
ClinicalTrials.gov Identifier: | NCT00692250 |
This study is designed to assess any potential interaction between colesevelam and ciclosporin in healthy volunteers.
Condition | Intervention | Phase |
---|---|---|
Familial Hypercholesterolemia |
Drug: Colesevelam hydrochloride film-coated tablets (Cholestagel) |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics Study |
Official Title: | A Phase I Open Label, Randomised, Single Dose, 2-Way Crossover, 2-Sequence Pharmacokinetic Study on the Interaction of Colesevelam and Ciclosporin in Healthy Volunteers |
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Genzyme Corporation ( Medical Monitor ) |
Study ID Numbers: | CHOL00207, EudraCT 2007-003724-38 |
Study First Received: | June 3, 2008 |
Last Updated: | June 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00692250 |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Lipid Metabolism, Inborn Errors Hypercholesterolemia, autosomal dominant Colesevelam Cyclosporine Hyperlipidemias Metabolic Diseases Hyperlipoproteinemia Type II Healthy |
Cyclosporins Metabolism, Inborn Errors Genetic Diseases, Inborn Metabolic disorder Hypercholesterolemia Hyperlipoproteinemias Dyslipidemias Lipid Metabolism Disorders |
Antimetabolites Immunologic Factors Molecular Mechanisms of Pharmacological Action Therapeutic Uses Antilipemic Agents |
Physiological Effects of Drugs Enzyme Inhibitors Anticholesteremic Agents Immunosuppressive Agents Pharmacologic Actions |