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A Study Conducted in Healthy Subjects to Demonstrate Bioequivalence Between Ropinirole Prolonged Release Tablets Manufactured at Crawley and Aranda

NCT01371682 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2018-06-19

No results posted yet for this study

Summary

This is an open-label, randomised, two-period crossover, single dose study to demonstrate bioequivalence between the extended release 2 mg ropinirole XL tablets manufactured at two different sites in healthy subjects. Dosing will be under fasting conditions and there will be a minimum one week washout between doses. Domperidone will be administered to control dopaminergic side effects. Pharmacokinetic samples will be taken following each dose. Safety assessments will include screening and follow-up vital signs, ECGs and safety laboratory tests. Vital signs and adverse events will be monitored periodically throughout the study.

Conditions

  • Parkinson Disease

Interventions

DRUG

Ropinirole XL

Ropinirole XL manufactured at Crawley will be compared to that manufactued at Aranda.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2009-09-18
Primary Completion
2009-12-02
Completion
2009-12-02

Countries

  • Belgium

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 NCT01371682 on ClinicalTrials.gov