Bioequivalence Study of Cabergoline Tablets and Dostinex Under Fed Conditions

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 Overview

• Status: Completed
• Conditions: To Determine Bioequivalence Under Fed Conditions
• Intervention / Treatment: Drug: Cabergoline; Drug: Dostinex

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Sainte-Foy, Quebec, Canada, G1V 2K8
      • Anapharm, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A; Subjects received the test product, Cabergoline 0.5 mg tablets under fed conditions	Drug: Cabergoline; Tablets 0.5 mg (2 x 0.5 mg dose), fed; Other Names: Dostinex
Active Comparator: B; Subjects received the reference product, Dostinex under fed conditions	Drug: Dostinex; Tablets, 0.5 mg (2 X 0.5 mg dose), fed; Other Names: Cabergoline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate and extent of absorption	240 hours

Collaborators and Investigators

• Sponsor: Par Pharmaceutical, Inc.
• Collaborators: Anapharm
• Investigators: Principal Investigator: Eric Masson, Pharm.D., Anapharm

Study record dates

Study Major Dates

• Study Start: July 1, 2001
• Primary Completion (Actual): December 1, 2001
• Study Completion (Actual): December 1, 2001

Study Registration Dates

• First Submitted: April 1, 2008
• First Submitted That Met QC Criteria: April 1, 2008
• First Posted (Estimate): April 4, 2008

Study Record Updates

• Last Update Posted (Actual): September 26, 2017
• Last Update Submitted That Met QC Criteria: September 22, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Bioequivalence; Fed; Cabergoline
• Additional Relevant MeSH Terms: Pathologic Processes; Nutrition Disorders; Disease; Malnutrition; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Dopamine Agonists; Dopamine Agents; Antiparkinson Agents; Anti-Dyskinesia Agents; Cabergoline
• Other Study ID Numbers: 01211