Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2026-03-01 @ 12:05 PM
Study NCT ID:
NCT02554734
Status:
COMPLETED
Last Update Posted:
2016-01-14
First Post:
2015-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetic Study in Healthy Volunteers
Sponsor:
Orion Corporation, Orion Pharma
Organization:
Study Overview
Official Title:
Pharmacokinetics of Levodopa After Repeated Doses of Carbidopa, ODM-104 and Levodopa: an Open, Randomised Study With Crossover Design in Healthy Males and Females
Status:
COMPLETED
Status Verified Date:
2016-01
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:
NOCOFPK2
Brief Summary:
Phase I open, randomized cross-over pharmacokinetic study.
Detailed Description:
The purpose of this study is to investigate the pharmacokinetics of levodopa, carbidopa, 3-OMD and ODM-104 after repeated doses of levodopa, carbidopa and ODM-104: an open, randomized, multicenter study with crossover design in healthy males and females.
Study Oversight
Has Oversight DMC:
False
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?: