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Ropinirole PR Food Effect and Dose Proportionality in Parkinson's Disease
NCT00460148Phase 2
Key facts
- Status
- Completed
- Start
- Apr 2007
- Countries
- 2
- Sponsor
- GSK
- Modality
- Small Molecules
- Drugs
- ropinirole
- Conditions
- Parkinson's disease (PD)
01
Overview
Phase 2, randomised, open-label trial of ropinirole in Parkinson's disease (PD) (2 arms), sponsored by GSK. Primary endpoints: Area under the plasma concentration-time curve at 24 hours and Maximum plasma concentration at 24 hours. Started Apr 2007; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Fasted State
Patients dosed with Ropinirole PR 12mg in the fasted state.
Fed State
Patients dosed with Ropinirole PR 12mg following a high-fat breakfast.
03
Who it enrols
Patients with idiopathic Parkinson's disease, aged 30-85, BMI 18-32, without significant sleep disorders, orthostatic hypotension, or recent history of drug abuse.
04
Endpoints
Primary
Area under the plasma concentration-time curve
Maximum plasma concentration
Secondary
Time to attain maximum plasma concentration
Incidence of adverse events
Vital signs
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