Ignite Creation Date:
2025-12-24 @ 1:17 PM
Ignite Modification Date:
2025-12-29 @ 11:58 PM
Study NCT ID:
NCT05192395
Status:
COMPLETED
Last Update Posted:
2022-07-11
First Post:
2022-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Crossover Study of DWJ1525 to Evaluate the Safety and Pharmacokinetic Properties in Healthy Volunteers
Sponsor:
Daewoong Pharmaceutical Co. LTD.
Organization:
Study Overview
Official Title:
A Crossover, Randomized, Open-label, Comparison Study Between DWJ1525 and the Concomitant Use of DWP16001 and DWC202101 to Evaluate the Safety and Pharmacokinetic Properties in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2021-11
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:
A Randomized, Open-label, Single Oral Dosing, Two-sequence, and Four-period Crossover Study to Evaluate the Pharmacokinetics and Safety Between the Administration of DWJ1525 and the Co-administration of DWP16001 and DWC202101 for Healthy Subjects in Fed and Fasted State
Detailed Description:
A single dose of the test (T) and two of the reference (R) products will be administered to the study subjects, according to a randomized, open-label, single oral dosing, two-sequence, and four-period crossover for healthy subjects in fed and fasted state study design.
A wash-out interval of at least 7 days will elapse between the each administrations.
The three investigational products will be administered with 150 mL of still mineral water on day 1 of the four study periods.
A wash-out interval of at least 7 days will elapse between the each administrations.
The three investigational products will be administered with 150 mL of still mineral water on day 1 of the four study periods.
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?:
None
Is an FDA AA801 Violation?: