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| Sponsor: | Par Pharmaceutical, Inc. |
|---|---|
| Collaborator: |
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: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label |
| 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 |
|---|---|
|
Experimental: A
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
Other Name: Dostinex
|
|
Active Comparator: B
Subjects received the reference product, Dostinex under fasting conditions
|
Drug: Dostinex
Tablets, 0.5 mg (2 x 0.5 mg dose), fasting
Other Name: Cabergoline
|
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: | Alfred Elvin/Director of Biopharmaceutics, Par Pharmaceutical, Inc. |
| ClinicalTrials.gov Identifier: | NCT00653055 History of Changes |
| Other Study ID Numbers: | 01210 |
| Study First Received: | April 1, 2008 |
| Last Updated: | April 3, 2008 |
| Health Authority: | United States: Food and Drug Administration |
|
Bioequivalence Cabergoline Fasting |
|
Disease Pathologic Processes Cabergoline Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antiparkinson Agents |
Anti-Dyskinesia Agents Central Nervous System Agents Dopamine Agonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |