Ignite Creation Date:
2024-05-06 @ 6:41 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05747664
Status:
RECRUITING
Last Update Posted:
2024-04-08
First Post:
2023-02-08
Brief Title:
To Compare the Safety and PKPD Characteristics of Subjects With Between Hepatic Impairment and Normal Hepatic Function
Sponsor:
Daewoong Pharmaceutical Co LTD
Organization:
Daewoong Pharmaceutical Co LTD
Study Overview
Official Title:
An Open-label Multi-center Parallel Single Oral Dose Study to Evaluate the Pharmacokinetics Pharmacodynamics Safety and Tolerability of DWP16001 in Subjects With Hepatic Impairment Compared With Subjects With Normal Hepatic Function
Status:
RECRUITING
Status Verified Date:
2024-04
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 pharmacokinetics pharmacodynamics safety and tolerability of DWP16001 in subjects with hepatic impairment compared with subjects with normal hepatic function
Detailed Description:
The study design is An open-label multi-center parallel single oral dose study
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?:
None