Bioequivalence Study of Cabergoline Tablets and Dostinex Under Fed Conditions
This study has been completed.
Information provided by:
Par Pharmaceutical, Inc.
First received: April 1, 2008
Last updated: NA
Last verified: April 2008
History: No changes posted
To compare the rate and extent of absorption of cabergoline 0.5 mg tablets (test) versus Dostinex (reference)
To Determine Bioequivalence Under Fed Conditions.
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
||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
Primary Outcome Measures:
- Rate and extent of absorption [ Time Frame: 240 hours ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||December 2001 (Final data collection date for primary outcome measure)
Subjects received the test product, Cabergoline 0.5 mg tablets under fed conditions
Tablets 0.5 mg (2 x 0.5 mg dose), fed
Other Name: Dostinex
Active Comparator: B
Subjects received the reference product, Dostinex under fed conditions
Tablets, 0.5 mg (2 X 0.5 mg dose), fed
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 fed conditions.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Subjects will be females or males, smokers or non-smokers
- 18 years of age and older
- Subjects should read, sign and date an Informed Consent Form prior to any study procedures
- Subjects must complete all screening procedures within 28 days prior to the administration of the study medication
- Breast feeding female subjects
- Clinically significant anormalities found during medical screening
- Any clinically significant gastrointestinal pathology or unresolved gastrointestinal symptoms susceptible of interfering with the absorption of drugs
- Clinically significant illnesses within 4 weeks of the administration of study medication
- Abnormal laboratory tests judged clinically significant
- ECG abnormalities or vital sign abnormalities at screening
- Subjects with BMI greater than or equal to 30.0
- History of allergic reactions to cabergoline or ergot derivatives
- Any food allergies, intolerances, restrictions, or special diet which in the opinion of the medical subinvestigator, contraindicates the subject's participation in the study
- Positive urine drug screen at screening
- Positive testing for hepatitis B, hepatitis C or HIV at screening
- Positive urine pregnancy test at screening (performed on all females)
- Use of investigational drug or participation in an investigational study, within 30 days prior to administration of the study medication
- Donation of plasma (500 mL) within 7 days or donation or significant loss of whole blood (450 mL) within 56 days prior to the administration of the study medication
- History of significant alcohol abuse within six months of the screening visit or any indication of the regular use of more than two units of alcohol per day
- History of drug abuse or use of illegal drugs: use of soft drugs (marijuana, pot) within 3 months of the screening visit or hard drugs (cocaine, PCP, crack)within 1 year of the screening visit
- Subjects who have taken prescription medication within 14 days prior to administration of study medication or over-the-counter products within 7 days prior to administration of study medication, except for topical products without systemic absorption
- Female subjects of childbearing potential who have had unprotected sexual intercourse with any non-sterile male partner (i.e. male who has not been sterilized by vasectomy for at last 6 months) within 14 days prior to the study drug administration. The acceptable methods of contraception are condom + spermicide (at least 14 days prior to study drug administration), diaphragm + spermicide (at least 14 days prior to study drug administration)or intrauterine contraceptive device (placed at least 4 weeks prior to study drug administration
- Subjects who have taken any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to administration of the study medication
- Subjects who have undergone clinically significant surgery within 4 weeks prior to the administration of the study medication
- Any reason which, in the opinion of the medical subinvestigator, would prevent the subject from participating in the study
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00652873
|Sainte-Foy, Quebec, Canada, G1V 2K8 |
Par Pharmaceutical, Inc.
||Eric Masson, Pharm.D.
No publications provided
||Alfred Elvin/Director of biopharmaceutics, Par Pharmaceutical, Inc.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 1, 2008
||April 1, 2008
||United States: Food and Drug Administration
Keywords provided by Par Pharmaceutical, Inc.:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 18, 2014
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs