Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2025-12-25 @ 3:06 PM
Study NCT ID:
NCT03090568
Status:
COMPLETED
Last Update Posted:
2017-03-27
First Post:
2017-03-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bioavailability Study of BIA 5-453
Sponsor:
Bial - Portela C S.A.
Organization:
Study Overview
Official Title:
Comparative Bioavailability Study of BIA 5-453 Under Fasted and Fed Conditions
Status:
COMPLETED
Status Verified Date:
2017-03
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:
The purpose of this study was to compare the bioavailability and tolerability of BIA 5-453 under fasted and fed conditions.
Detailed Description:
This was a Single-centre, two-way crossover, randomised, open-label study in 12 healthy male volunteers. Subjects received a single oral 200 mg dose of BIA 5-453 following a standard meal in one period, and following at least 10 hours of fasting in another period. Treatment periods were separated by a washout interval of 2 weeks or more.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: