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Sponsors and Collaborators: |
Par Pharmaceutical, Inc. Anapharm |
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Information provided by: | Par Pharmaceutical, Inc. |
ClinicalTrials.gov Identifier: | NCT00652873 |
To compare the rate and extent of absorption of cabergoline 0.5 mg tablets (test) versus Dostinex (reference)
Condition | Intervention | Phase |
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To Determine Bioequivalence Under Fed Conditions. |
Drug: Cabergoline Drug: Dostinex |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
Official Title: | Randomized, 2-Way Crossover, Bioequivalence Study of Cabergoline 0.5 mg Tablets and Dostinex 0.5 mg Tablets Administered as 2 x 0.5 mg Tablets in Healthy Adult Females and Males Under Fed Conditions |
Enrollment: | 24 |
Study Start Date: | July 2001 |
Study Completion Date: | December 2001 |
Primary Completion Date: | December 2001 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Subjects received the test product, Cabergoline 0.5 mg tablets under fed conditions
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Drug: Cabergoline
Tablets 0.5 mg (2 x 0.5 mg dose), fed
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B: Active Comparator
Subjects received the reference product, Dostinex under fed conditions
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Drug: Dostinex
Tablets, 0.5 mg (2 X 0.5 mg dose), fed
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To compare the rate and extent of absorption of cabergoline 0.5 mg tablets (test) versus Dostinex (reference) administered as 2 x 0.5 mg tablets under fed conditions.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Par Pharmaceutical, Inc. ( Alfred Elvin/Director of biopharmaceutics ) |
Study ID Numbers: | 01211 |
Study First Received: | April 1, 2008 |
Last Updated: | April 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00652873 |
Health Authority: | United States: Food and Drug Administration |
Bioequivalence Cabergoline Fed |
Dopamine Malnutrition Nutrition Disorders Healthy Cabergoline |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs |
Antiparkinson Agents Dopamine Agents Dopamine Agonists Central Nervous System Agents Pharmacologic Actions |