Ignite Creation Date:
2025-12-24 @ 2:43 PM
Ignite Modification Date:
2026-01-04 @ 5:41 PM
Study NCT ID:
NCT06109259
Status:
UNKNOWN
Last Update Posted:
2023-10-31
First Post:
2023-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1567 in Healthy Adult Volunteers
Sponsor:
Daewoong Pharmaceutical Co. LTD.
Organization:
Study Overview
Official Title:
An Open-label, Randomized, 2x4 Crossover Study to Compare the Pharmacokinetics and Safety Following Administration of DWJ1567 and DWC202312 in Healthy Volunteers
Status:
UNKNOWN
Status Verified Date:
2023-10
Last Known Status:
RECRUITING
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:
This study aims to compare the pharmacokinetics and safety following administration of DWJ1567 and DWC202312 in healthy volunteers
Detailed Description:
The study design is a Randomized, Open-label, Oral, Single-dose, Four-way crossover study. The patients were randomly assigned to each group. Primary endpoint was Cmax and AUCt of DWJ1567 and DWC202312. Secondary endpoints were AUCinf, Tmax, t1/2 of DWJ1567 and DWC202312.
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?: