Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00460148
Status:
COMPLETED
Last Update Posted:
2016-10-28
First Post:
2007-04-11
Brief Title:
Parkinsons Disease Patient Study On Absorption Distribution Metabolism And Excretion Of Ropinirole
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
An Open Label Repeat Dose Dose Escalation Study Conducted in Parkinsons Disease Patients to Characterize the Pharmacokinetics and Effect of Food on Ropinirole Prolonged Release PRCR 12mg Tablets
Status:
COMPLETED
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None