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

Parkinson Disease Clinical Trial

Official title: An Open Label Study Conducted in Healthy Subjects to Demonstrate Bioequivalence Between Ropinirole Prolonged Release Tablets (Ropinirole XL, Marketed as REQUIP-MODUTAB™, REQUIP XL™ at 2 mg) Manufactured at Crawley and Aranda

Status Completed

Clinical Trial 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.

Clinical Trial Description

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.

The manufacturing of ropinirole XL tablets will be moved from the Crawley (UK) manufacturing facility to the Aranda (Spain) manufacturing facility. The tablets manufactured at Aranda will have the same characteristics as those manufactured at Crawley.

The present pharmacokinetic study is designed to assess bioequivalence of ropinirole XL 2 mg tablets manufactured at Aranda vs ropinirole XL 2 mg tablets manufactured at Crawley. Bioequivalence between the two tablets will be tested in healthy subjects and administered in the fasting state. ;

Related Conditions & MeSH terms

• Parkinson Disease

• NCT number: NCT01371682
• Study type: Interventional
• Source: GlaxoSmithKline
• Status: Completed
• Phase: Phase 1
• Start date: September 18, 2009
• Completion date: December 2, 2009