To Determine Bioequivalence Under Fasting Conditions Clinical Trial
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
Verified date | April 2008 |
Source | Par Pharmaceutical, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
To compare the rate and extent of absorption of cabergoline 0.5 mg tablets (test) versus Dostinex (reference)
Status | Completed |
Enrollment | 40 |
Est. completion date | December 2001 |
Est. primary completion date | December 2001 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - Breast feeding female subjects - Clinically significant abnormalities 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 |
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
Canada | Anapharm, Inc. | Sainte-Foy | Quebec |
Lead Sponsor | Collaborator |
---|---|
Par Pharmaceutical, Inc. | Anapharm |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate and extent of absorption | 240 hours | No |
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