Bioequivalence Study of Cabergoline Tablets and Dostinex Under Fed Conditions

Sponsor

Par Pharmaceutical, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00652873

Collaborator

Anapharm (Industry)

Enrollment

Location

Arms

Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
To Determine Bioequivalence Under Fed Conditions	Drug: Cabergoline Drug: Dostinex	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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 Start Date :

Jul 1, 2001

Actual Primary Completion Date :

Dec 1, 2001

Actual Study Completion Date :

Dec 1, 2001

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Rate and extent of absorption [240 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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