Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2026-02-22 @ 7:03 AM
Study NCT ID:
NCT03914534
Status:
COMPLETED
Last Update Posted:
2019-04-16
First Post:
2019-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of Sodium Divalproate Tablets 500 mg
Sponsor:
Tecnoquimicas
Organization:
Study Overview
Official Title:
Bioequivalence Study of Sodium Divalproate Tablets 500 mg
Status:
COMPLETED
Status Verified Date:
2019-04
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 objective of this study is to establish the bioequivalence of two valproic acid formulations through the estimation of valproic acid in plasma samples, according to Food and Drugs Administration (FDA), World Health Organization (WHO) and Colombian National Vigilance Institute for Drugs and Food (INVIMA) guidelines.
Detailed Description:
This will be a single-center, open-label, four-period, two-treatment, two-sequence, randomized, single-dose, crossover study. 30 healthy adults will be randomized to receive a single dose (500 mg) of the test formulation of valproic acid and reference formulation of valproic acid separately in each treatment period. There will be two treatment sequences (AB, BA) and a 7 day washout between the two treatment periods.
Study Oversight
Has Oversight DMC:
True
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?: