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Bioequivalence Study of Cabergoline Tablets and Dostinex Under Fasting Conditions

Information source: Par Pharmaceutical, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: To Determine Bioequivalence Under Fasting Conditions

Intervention: Cabergoline (Drug); Dostinex (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Par Pharmaceutical, Inc.

Official(s) and/or principal investigator(s):
Eric Masson, Pharm.D., Principal Investigator, Affiliation: Anapharm

Summary

To compare the rate and extent of absorption of cabergoline 0. 5 mg tablets (test) versus Dostinex (reference)

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome: Rate and extent of absorption

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Anapharm, Inc., Sainte-Foy, Quebec GiV 2K8, Canada
Additional Information

Starting date: August 2001
Last updated: April 3, 2008

Page last updated: August 23, 2015

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