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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- PK samples will be measured for each formulation and compared between sites. The units of measure for this will include PK parameters, for example, Bioavailability, clearance and volume of distribution and Area under the curve.
Study Overview
Brief 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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Session 1
Ropinirole manufactued at Crawley will be compared to that manufactured at Aranda
Intervention: Ropinirole XL (Drug)
Session 2
Ropinirole manufactured at Crawley will be compared to that manufactured at Aranda.
Intervention: Ropinirole XL (Drug)
Outcomes
Primary Outcomes
PK samples will be measured for each formulation and compared between sites. The units of measure for this will include PK parameters, for example, Bioavailability, clearance and volume of distribution and Area under the curve.
Time Frame: 6 months
PK parameters used to measure this change : AUC(0-infinity), AUC(0-t), Cmax, tmax, lambda - z and t1/2
Secondary Outcomes
- Safety values including Vital signs, BP, ECG values will be taken from the study for each cohort dosed with each formulation. The change in values will be compared from each formulation and any change bewteeen the two cohorts will be examined.(6 months)