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Restless Legs Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole And The Effect Of Food

NCT00419692 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2017-10-13

No results posted yet for this study

Summary

This study in RLS patients is designed to assess the affect food has on the absorption, distribution, metabolism and excretion of ropinirole (by dosing some patients in the fasted state and other patients following a high-fat breakfast), and to assess the difference in absorption, distribution, metabolism and excretion of ropinirole if patients are given two 3mg ropinirole tablets versus one 6mg tablet.

Conditions

  • Restless Legs Syndrome

Interventions

DRUG

Ropinirole

Subjects will receive ropinirole 0.5 mg for first 7 days, 1 mg from Day 8-14, 2 mg from Day 15-21, 3 mg from Day 22-28, 4 mg from Day 29-35, 5 mg from Day 36-42 and 6 mg from Day 43-51.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-24
Primary Completion
2006-12-12
Completion
2006-12-12

Countries

  • Germany
  • South Africa

Study Locations

More Related Trials

Entities

Companies

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 NCT00419692 on ClinicalTrials.gov