Overview

Bioequivalence Study of Cabergoline Tablets and Dostinex Under Fed Conditions

Status:
Completed
Trial end date:
2001-12-01
Target enrollment:
0
Participant gender:
All
Summary
To compare the rate and extent of absorption of cabergoline 0.5 mg tablets (test) versus Dostinex (reference)
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Par Pharmaceutical, Inc.
Collaborator:
Anapharm
Treatments:
Cabergoline
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 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