Bioequivalence Study of Cabergoline Tablets and Dostinex Under Fasting Conditions

Par Pharmaceutical

Status and phase

Completed

Phase 1

Conditions

To Determine Bioequivalence Under Fasting Conditions

Treatments

Drug: Cabergoline

Drug: Dostinex

Study type

Interventional

Funder types

Industry

Identifiers

NCT00653055

01210

Details and patient eligibility

About

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

Full 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 fasting conditions.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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