Ropinirole PR Pharmacokinetics Study Among Chinese Healthy Subjects
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|ClinicalTrials.gov Identifier: NCT01435915|
Recruitment Status : Completed
First Posted : September 19, 2011
Last Update Posted : May 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Drug: Ropinirole||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single Dose and Repeat Dose Study to Investigate the Pharmacokinetics of Ropinirole After Single and Multiple Doses of a PR-formulation in Chinese Healthy Male and Female Subjects|
|Actual Study Start Date :||June 28, 2010|
|Actual Primary Completion Date :||August 5, 2010|
|Actual Study Completion Date :||August 5, 2010|
Experimental: Subjects receiving ropinirole
Eligible subjects will receive single and multiple oral dose of ropinirole prolonged release tablet in sequence over 14 days without dosing on washout period from Day 2 to Day 7.
Ropinirole 2 milligrams once daily prolonged release tablet will be given at 24-hour intervals in the morning.
Single and repeat dose treatment periods will be separated by 7 days of washout period.
- Profile of Pharmacokinetics [ Time Frame: predose,1,2,3,4,6,8,10,12,14,16,18,20,22,24,36,48,72, 96,120,144,168 hours post-dose ]Cmax, AUC (0-24), AUC(0-inf)
- Profile of Pharmacokinetics [ Time Frame: predose,1,2,3,4,6,8,10,12,14,16,18,20,22,24 hours after last repeated dosing ]Css_max, Css_min and AUCss
- Profile of Pharmacokinetics [ Time Frame: pre-dose,1,2,3,4,6,8,10,12,14,16,18,20,22, 24,36,48,72,96,120,144,168hours post-dose ]Tmax, T1/2, Kel
- Composition of Pharmacokinetics [ Time Frame: predose,1,2,3,4,6,8,10,12,14,16,18,20,22,24 hours after last repeated dosing ]Tmax, Css_av, DF，accumulation ratios (Ro and Rs)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01435915
|GSK Investigational Site|
|Beijing, China, 100032|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|