Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-30 @ 3:32 AM
Study NCT ID:
NCT06308068
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-13
First Post:
2024-03-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of Diacerein 50 mg Capsule in Healthy Thai Volunteers
Sponsor:
International Bio service
Organization:
Study Overview
Official Title:
A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Diacerein 50 mg Capsule and Reference Product (ARTRODAR®) in Healthy Thai Volunteers Under Fed Conditions
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
To determine and compare the rate and extent of absorption of a test formulation with that of a reference innovator formulation when given as equal labeled dose in healthy subjects under fed conditions
Detailed Description:
This study is conducted to investigate bioequivalence information which is required to ensure therapeutic equivalence of a test product and a reference product as well as to be considered as one aspect of product quality. Bioequivalence is defined as the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study.
An open label, randomized, two-treatment, two-period, two-sequence, single oral dose, crossover bioequivalence study in healthy Thai volunteers under fed conditions with at least 7 days washout period between the administrations of investigational products of two consecutive periods.
An open label, randomized, two-treatment, two-period, two-sequence, single oral dose, crossover bioequivalence study in healthy Thai volunteers under fed conditions with at least 7 days washout period between the administrations of investigational products of two consecutive periods.
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?: