| April 11, 2007 |
| October 9, 2008 |
| April 2007 |
| |
| Ropinirole AUC, the area under the plasma concentration-time curve over 24 hours
Ropinirole maximum plasma concentration over 24 hours [ Time Frame: 24 hours ] |
| Ropinirole AUC, the area under the plasma concentration-time curve over 24 hours
Ropinirole maximum plasma concentration over 24 hours |
| Complete list of historical versions of study NCT00460148 on ClinicalTrials.gov Archive Site |
- Time to attain the maximum plasma concentration
Incidence of adverse events over 37 days
As above, but for ropinirole metabolites [ Time Frame: over 37 days ]
- Vital signs, ECG and clinical laboratory data over 37 days [ Time Frame: over 37 days ]
|
| Time to attain the maximum plasma concentration
Incidence of adverse events over 37 days
Vital signs, ECG and clinical laboratory data over 37 days
As above, but for ropinirole metabolites |
| |
| Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole |
| An Open Label, Repeat Dose, Dose Escalation Study Conducted in Parkinson's Disease Patients to Characterize the Pharmacokinetics and Effect of Food on Ropinirole Prolonged Release (PR/CR) 12mg Tablets. |
This study in PD patients is designed to assess the affect food has on the absorption, distribution, metabolism and excretion of ropinirole (by dosing some patients in the fasted state and other patients following a high-fat breakfast), and to assess the difference in absorption, distribution, metabolism and excretion of ropinirole if patients are given three 4mg ropinirole tablets versus one 12mg tablet. |
| |
| Phase II |
| Interventional |
| Treatment, Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study |
| Parkinson's Disease |
| Drug: Ropinirole |
| |
| |
| |
| Completed |
| 28 |
| August 2007 |
|
Inclusion Criteria:
- Male or female patients aged between 30 and 85 years of age
- Body mass index of 18 to 32 kg/m2, body weight of at least 50 kg.
- Diagnosis of idiopathic Parkinson's disease
- Patients must have provided written informed consent prior to performing any study procedures
- QTc interval of < 450ms (or QTc < 480ms in patients with Bundle Branch Block).
Exclusion Criteria:
|
| Both |
| 30 Years to 85 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Germany, South Africa |
| |
| NCT00460148 |
| Study Director, GSK |
| ROP109087 |
| GlaxoSmithKline |
|
| Study Director: |
GSK Clinical Trials, PhD |
GlaxoSmithKline |
|
|
| GlaxoSmithKline |
| October 2008 |