Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2026-01-02 @ 1:31 AM
Study NCT ID:
NCT06549504
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-14
First Post:
2024-08-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of AG2202
Sponsor:
Ahn-Gook Pharmaceuticals Co.,Ltd
Organization:
Study Overview
Official Title:
An Open-label, Randomized, Fasting, Single, Oral Administration, Group 2, Stage 2, Cross-over Bioequivalence Study of AG2202 in Healthy Volunteers
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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 evaluate the human bioequivalence of AG2202T and AG2202R.
Detailed Description:
To evaluate the bioequivalence of two formulations of AG2202T and AG2202R after a single oral dose administration in healthy Korean subjects under fasting conditions.
Study Oversight
Has Oversight DMC:
None
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?:
False
Is an FDA AA801 Violation?: