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The Relative Bioavailability Study of Two Ropinirole 0.25 mg Tablets Under Fed Conditions

NCT00830219 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2009-09-15

Study results available
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Summary

The purpose of this study is to compare relative bioavailability of the test formulation of ropinirole hydrochloride 0.25 mg tablets (Manufactured and distributed by TEVA Pharmaceuticals USA) with the already approved formulation REQUIP® (ropinirole hydrochloride) 0.25 mg tablets (GlaxoSmithKline) under fed conditions in healthy, adult subjects.

Conditions

  • Healthy

Interventions

DRUG

Ropinirole HCl 0.25 mg Tablets

1 x 0.25 mg, single dose fed

DRUG

Requip® 0.25 mg Tablets

1 x 0.25 mg, single dose fed

Sponsors & Collaborators

  • Teva Pharmaceuticals USA

    lead INDUSTRY

Principal Investigators

  • So Ran Hong, M.D. · Novum Pharmaceutical 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
2004-11-30
Primary Completion
2004-11-30
Completion
2004-11-30

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 NCT00830219 on ClinicalTrials.gov