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Ropinirole 0.25 mg Tablets Under Fasting Conditions

NCT00829504 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2009-09-11

Study results available
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Summary

The objective of this study was to compare the relative bioavailability of the test formulation of Ropinirole (TEVA Pharmaceuticals USA) with already marketed reference of Requip® (Manufactured by SmithKline Beecham Pharmaceuticals for GlaxoSmithKline) under fasting conditions in healthy, non-smoking, adult subjects.

Conditions

  • Healthy

Interventions

DRUG

Ropinirole HCl 0.25 mg Tablets

1 x 0.25 mg

DRUG

Requip® 0.25 mg Tablets

1 x 0.25 mg

Sponsors & Collaborators

  • Teva Pharmaceuticals USA

    lead INDUSTRY

Principal Investigators

  • Soran Hong, M.D. · Novum Pharmaceuticals Research Services

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-10-31
Primary Completion
2004-10-31
Completion
2004-10-31

Countries

  • United States

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 NCT00829504 on ClinicalTrials.gov