Clinical trial NCT00653055: Bioequivalence Study of Cabergoline Tablets and Dostinex Under Fasting Conditions
Official title: Randomized, 4-Way Replicate 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 Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: To Determine Bioequivalence Under Fasting Conditions
Keywords: Bioequivalence
Cabergoline
Fasting
Lead sponsor: Par Pharmaceutical, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Anapharm
First posted: 2008-04-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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 fasting conditions.

Eligibility criteria: 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

Primary outcomes:
measure: Rate and extent of absorption
timeFrame: 240 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Sainte-Foy
country: Canada
facility: Anapharm, Inc.
state: Quebec
Study officials:
affiliation: Anapharm
name: Eric Masson, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
References: