Bioequivalence Study of Cabergoline Tablets and Dostinex Under Fed Conditions

NCT00652873 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-09-26

No results posted yet for this study

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

Interventions

DRUG

Cabergoline

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

DRUG

Dostinex

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

Sponsors & Collaborators

  • Anapharm

    collaborator INDUSTRY
  • Par Pharmaceutical, Inc.

    lead INDUSTRY

Principal Investigators

  • Eric Masson, Pharm.D. · Anapharm

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2001-07-31
Primary Completion
2001-12-31
Completion
2001-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00652873 on ClinicalTrials.gov