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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00415831 |
The purpose of this study is to assess the safety and bioequivalence of a single oral dose of carbidopa+levodopa+entacapone combination versus a single oral dose of carbidopa+levodopa combination plus a single oral dose of entacapone under fed conditions in healthy volunteers.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: ELC200 (carbidopa+levodopa+entacapone) |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study |
Official Title: | A Randomized, Two-Way Crossover Study to Investigate the Bioavailability of a Single Oral Dose of 12.5 mg Carbidopa, 50 mg Levodopa and 200 mg Entacapone Compared to a Single Oral Combined Dose of Both 12.5 mg Carbidopa and 50 mg Levodopa and 200 mg Entacapone in Healthy Volunteers Under Fed Conditions |
Estimated Enrollment: | 42 |
Study Start Date: | June 2006 |
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Study ID Numbers: | CELC200A2102 |
Study First Received: | December 22, 2006 |
Last Updated: | June 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00415831 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Bioequivalence bioavailability carbidopa levodopa |
entacapone fed condition Healthy volunteers study |
Levodopa Dopamine Malnutrition Sinemet |
Carbidopa Healthy Entacapone |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Immunologic Factors Anti-Dyskinesia Agents Physiological Effects of Drugs Adjuvants, Immunologic Antiparkinson Agents |
Enzyme Inhibitors Dopamine Agonists Pharmacologic Actions Therapeutic Uses Dopamine Agents Central Nervous System Agents |