Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Par Pharmaceutical, Inc. Anapharm |
---|---|
Information provided by: | Par Pharmaceutical, Inc. |
ClinicalTrials.gov Identifier: | NCT00653055 |
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.
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: | 01210 |
Study First Received: | April 1, 2008 |
Last Updated: | April 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00653055 |
Health Authority: | United States: Food and Drug Administration |
Bioequivalence Cabergoline Fasting |
Naphazoline Oxymetazoline Dopamine Guaifenesin |
Phenylephrine Phenylpropanolamine 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 |