Bioequivalence Study of Cabergoline Tablets and Dostinex Under Fed Conditions

Phase 1

Completed

• Conditions: To Determine Bioequivalence Under Fed Conditions
• Interventions: Drug: Dostinex; Drug: Cabergoline

• Registration Number: NCT00652873
• Lead Sponsor: Par Pharmaceutical, Inc.

Brief Summary

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

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 Timeline

• Study Start: 2001-07
• Primary Completion: 2001-12
• Study Completion: 2001-12
• Study First Submitted: 2008-04-01
• Study First Submitted QC: 2008-04-01
• Study First Posted: 2008-04-04
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-22
• Last Update Posted: 2017-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
B	Dostinex	Subjects received the reference product, Dostinex under fed conditions
A	Cabergoline	Subjects received the test product, Cabergoline 0.5 mg tablets under fed conditions

Primary Outcome Measures

Name	Time	Method
Rate and extent of absorption	240 hours

Trial Locations

Locations (1)

Anapharm, Inc.; 🇨🇦 Sainte-Foy, Quebec, Canada