Ignite Creation Date:
2025-12-24 @ 2:01 PM
Ignite Modification Date:
2026-01-19 @ 3:42 PM
Study NCT ID:
NCT06592495
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-09-23
First Post:
2024-08-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioepuivalence Study for the Safety and the Pharmacokinetics of DWJ1589 and DWC202315
Sponsor:
Daewoong Pharmaceutical Co. LTD.
Organization:
Study Overview
Official Title:
Bioepuivalence Study for the Safety and the Pharmacokinetics of DWJ1589 and DWC202315 in Healthy Adult Volunteers Under Fasting Conditions
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
This study aims to evaluate the safety and pharmacokinetic characteristics after administration of DWJ1589 and DWC202315 in healty adult volunteers.
Detailed Description:
The study design is a Randomized, Open-label, Oral, Single-dose, 2 × 4 crossover study. The patients were randomly assigned to each group. Primary endpoint was Cmax and AUClast of DWJ1589 and DWC202315. Secondary endpoints were AUCinf, AUClast/AUCinf, Tmax and t1/2 of DWJ1589 and DWC202315.
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?:
False
Is an FDA AA801 Violation?: