Official Title: “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”

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

Study Type: Interventional

Study Design: Other, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study

Study Primary Completion Date: December 2001

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

Intervention(s) in this Clinical Trial

• Drug: Cabergoline
  • Tablets 0.5 mg (2 x 0.5 mg dose), fed
• Drug: Dostinex
  • Tablets, 0.5 mg (2 X 0.5 mg dose), fed

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
  • Subjects received the test product, Cabergoline 0.5 mg tablets under fed conditions
• Active Comparator: B
  • Subjects received the reference product, Dostinex under fed conditions

Primary Measures

• Rate and extent of absorption
  • Time Frame: 240 hours
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Par Pharmaceutical, Inc.

Overall Clinical Trial Officials and Contacts

Eric Masson, Pharm.D. Principal Investigator Anapharm  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00652873

Study ID Number: 01211

ClinicalTrials.gov Identifier: NCT00652873

Health Authority: United States: Food and Drug Administration