Ignite Creation Date:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2025-12-26 @ 11:46 AM
Study NCT ID:
NCT01533116
Status:
COMPLETED
Last Update Posted:
2015-11-16
First Post:
2012-01-24
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Effect of BIA 9-1067 at Steady-state on the Pharmacokinetics of Levodopa/Carbidopa and Levodopa/Benserazide
Sponsor:
Bial - Portela C S.A.
Organization:
Study Overview
Official Title:
Effect of BIA 9-1067 at Steady-state on the Pharmacokinetics of a Single-dose of Immediate-release 100/25 mg Levodopa/Carbidopa and 100/25 mg Levodopa/Benserazide in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2015-10
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:
To investigate the effect of BIA 9-1067 in steady-state conditions on the levodopa pharmacokinetics
Detailed Description:
Single centre, randomized, double-blind, gender-balanced, placebo-controlled study in 4 groups of healthy subjects
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?: