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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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 August 21, 2014
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs