Bioequivalence Study of Cabergoline Tablets and Dostinex Under Fed Conditions

• Status: Completed
• Trial end date: 2001-12-01
• Target enrollment: 0
• Participant gender: All

Summary

To compare the rate and extent of absorption of cabergoline 0.5 mg tablets (test) versus Dostinex (reference)

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Par Pharmaceutical, Inc.
• Collaborator: Anapharm
• Treatments: Cabergoline

Criteria

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 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