Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2026-01-10 @ 12:23 AM
Study NCT ID:
NCT03095105
Status:
COMPLETED
Last Update Posted:
2017-03-30
First Post:
2017-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetic Profile of BIA 6-512 in Healthy Elderly Subjects Versus Healthy Young Subjects
Sponsor:
Bial - Portela C S.A.
Organization:
Study Overview
Official Title:
An Open-label, Parallel-group Study to Compare the Pharmacokinetic Profile in Healthy Elderly Subjects Versus Healthy Young Subjects After Single and Repeated Oral Administration of BIA 6-512 (Trans-resveratrol)
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 the study was to the compare pharmacokinetic profile of BIA 6-512 in healthy elderly subjects versus healthy young subjects after single and repeated oral administration of 200 mg BIA 6-512.
Detailed Description:
Single-centre, open-label study in healthy young (18-40 years) and elderly (65 years or older) subjects. The study consisted of a single-dose phase followed by a repeated dose phase (3 times daily, at 8-h intervals). Subjects were admitted on the day prior to the first dose (Day 1). On day 1, a single dose of 200 mg BIA 6-512 (Dose 1) was administered in the morning. On day 2, the repeated dose phase started 24 h post first dosing. In the repeated dose phase (Doses 2 to 8) subjects received 200 mg BIA 6-512 every 8 hours until the morning of day 4 (approximately 72 hours post first dosing).
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?: