Bioequivalence Study of Cabergoline Tablets and Dostinex Under Fasting Conditions

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”

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

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),fasting
• Drug: Dostinex
  • Tablets, 0.5 mg (2 x 0.5 mg dose), fasting

Arms, Groups and Cohorts in this Clinical Trial

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

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 Investigator: Par Pharmaceutical, Inc. Industry

Overall Clinical Trial Officials and Contacts

Eric Masson, Pharm.D. Principal Investigator Anapharm  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00653055

Study ID Number: 01210

ClinicalTrials.gov Identifier: NCT00653055

Health Authority: United States: Food and Drug Administration