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| Sponsors and Collaborators: |
Par Pharmaceutical, Inc. Anapharm |
|---|---|
| Information provided by: | Par Pharmaceutical, Inc. |
| ClinicalTrials.gov Identifier: | NCT00653055 |
Purpose
To compare the rate and extent of absorption of cabergoline 0.5 mg tablets (test) versus Dostinex (reference)
| Condition | Intervention | Phase |
|---|---|---|
|
To Determine Bioequivalence Under Fasting Conditions |
Drug: Cabergoline Drug: Dostinex |
Phase I |
| Study Type: | Interventional |
| Study Design: | Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
| Official Title: | Randomized, 4-Way Replicate 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 Fasting Conditions |
| Enrollment: | 40 |
| Study Start Date: | August 2001 |
| Study Completion Date: | December 2001 |
| Primary Completion Date: | December 2001 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: Experimental
Subjects received the test product, Cabergoline 0.5 mg tablets under fasting conditions
|
Drug: Cabergoline
Tablets, 0.5 mg (2 x 0.5 mg dose),fasting
|
|
B: Active Comparator
Subjects received the reference product, Dostinex under fasting conditions
|
Drug: Dostinex
Tablets, 0.5 mg (2 x 0.5 mg dose), fasting
|
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 fasting conditions.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Par Pharmaceutical, Inc. ( Alfred Elvin/Director of Biopharmaceutics ) |
| Study ID Numbers: | 01210 |
| Study First Received: | April 1, 2008 |
| Last Updated: | April 3, 2008 |
| ClinicalTrials.gov Identifier: | NCT00653055 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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Bioequivalence Cabergoline Fasting |
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Oxymetazoline Neurotransmitter Agents Dopamine Phenylephrine |
Dopamine Agents Healthy Dopamine Agonists 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 Cabergoline Pharmacologic Actions |