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Bioequivalence Study of Cabergoline Tablets and Dostinex Under Fed Conditions
This study has been completed.
First Received: April 1, 2008   No Changes Posted
Sponsor: Par Pharmaceutical, Inc.
Collaborator: Anapharm
Information provided by: Par Pharmaceutical, Inc.
ClinicalTrials.gov Identifier: NCT00652873
  Purpose

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


Condition Intervention Phase
To Determine Bioequivalence Under Fed Conditions.
Drug: Cabergoline
Drug: Dostinex
Phase I

Study Type: Interventional
Study Design: Randomized, Open Label, Crossover Assignment, Bio-equivalence Study
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

Resource links provided by NLM:


Further study details as provided by Par Pharmaceutical, Inc.:

Primary Outcome Measures:
  • Rate and extent of absorption [ Time Frame: 240 hours ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: July 2001
Study Completion Date: December 2001
Primary Completion Date: December 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental
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
B: Active Comparator
Subjects received the reference product, Dostinex under fed conditions
Drug: Dostinex
Tablets, 0.5 mg (2 X 0.5 mg dose), fed

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00652873

Locations
Canada, Quebec
Anapharm, Inc.
Sainte-Foy, Quebec, Canada, G1V 2K8
Sponsors and Collaborators
Par Pharmaceutical, Inc.
Anapharm
Investigators
Principal Investigator: Eric Masson, Pharm.D. Anapharm
  More Information

No publications provided

Responsible Party: Par Pharmaceutical, Inc. ( Alfred Elvin/Director of biopharmaceutics )
Study ID Numbers: 01211
Study First Received: April 1, 2008
Last Updated: April 1, 2008
ClinicalTrials.gov Identifier: NCT00652873     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Par Pharmaceutical, Inc.:
Bioequivalence
Cabergoline
Fed

Additional relevant MeSH terms:
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Antiparkinson Agents
Dopamine Agonists
Pharmacologic Actions
Malnutrition
Therapeutic Uses
Nutrition Disorders
Dopamine Agents
Cabergoline
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009