Bioequivalence Study of Cabergoline Tablets and Dostinex Under Fed Conditions

NCT00652873 | Completed Phase 1

• 1 other identifier: 01211
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

To Determine Bioequivalence Under Fed Conditions

Keywords

Bioequivalence; Cabergoline; Fed

Outcome Measures

Primary Outcomes (1)

• Rate and extent of absorption

  240 hours

Study Arms (2)

A

EXPERIMENTAL

Subjects received the test product, Cabergoline 0.5 mg tablets under fed conditions

Drug: Cabergoline

B

ACTIVE COMPARATOR

Subjects received the reference product, Dostinex under fed conditions

Drug: Dostinex

Interventions

Cabergoline DRUG

Tablets 0.5 mg (2 x 0.5 mg dose), fed

Also known as: Dostinex

A

Dostinex DRUG

Tablets, 0.5 mg (2 X 0.5 mg dose), fed

Also known as: Cabergoline

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects will be females or males, smokers or non-smokers
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Par Pharmaceutical, Inc.: lead
• Anapharm: collaborator

Study Sites (1)

Anapharm, Inc.

Sainte-Foy, Quebec, G1V 2K8, Canada

Location

MeSH Terms

Conditions

Lecithin Cholesterol Acyltransferase Deficiency

Interventions

Cabergoline

Condition Hierarchy (Ancestors)

Hypoalphalipoproteinemias; Hypolipoproteinemias; Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Ergolines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring

Study Officials

• Eric Masson, Pharm.D.

  Anapharm

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 1, 2008
• First Posted: April 4, 2008
• Study Start: July 1, 2001
• Primary Completion: December 1, 2001
• Study Completion: December 1, 2001
• Last Updated: September 26, 2017

Record last verified: 2017-09

Locations

CA (1)