Bioequivalence Study of Cabergoline Tablets and Dostinex Under Fed Conditions

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2001

Detailed Description

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.

Interventions

  • 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

  • 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

Clinical Trial Outcome Measures

Primary Measures

  • Rate and extent of absorption
    • Time Frame: 240 hours

Participating in This Clinical Trial

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: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Par Pharmaceutical, Inc.
  • Collaborator
    • Anapharm
  • Provider of Information About this Clinical Study
    • Alfred Elvin/Director of biopharmaceutics, Par Pharmaceutical, Inc.
  • Overall Official(s)
    • Eric Masson, Pharm.D., Principal Investigator, Anapharm

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.