Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2026-02-25 @ 9:42 PM
Study NCT ID:
NCT04952506
Status:
COMPLETED
Last Update Posted:
2024-01-24
First Post:
2021-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study to Compare the Pharmacokinetics and Safety of D113 With CKD-349 in Healthy Volunteers
Sponsor:
Chong Kun Dang Pharmaceutical
Organization:
Study Overview
Official Title:
A Randomized, Open-label, Single-dosing, 3-treatment, 6-sequence, 3-period, Crossover-design Pilot Clinical Trial to Compare the Safety and Pharmacokinetics of D113 With CKD-349 in Healthy Adult Volunteers
Status:
COMPLETED
Status Verified Date:
2024-01
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 is a randomized, open-label, single dosing, 3-treatment, 6-sequence, 3-period, crossover-design study to compare the pharmacokinetics and safety of D113 with CKD-349 in healthy volunteers.
Detailed Description:
To healthy subjects of twenty-four (24), following treatments are administered dosing in each period and wash-out period is a minimum of 7 days.
Reference drug: Entresto 200mg / Test drug: 1) CKD-349 F1 Tab. 2) CKD-349 F2 Tab.
Pharmacokinetic blood samples are collected up to 48hrs. The pharmacokinetic characteristics and safety are assessed.
Reference drug: Entresto 200mg / Test drug: 1) CKD-349 F1 Tab. 2) CKD-349 F2 Tab.
Pharmacokinetic blood samples are collected up to 48hrs. The pharmacokinetic characteristics and safety are assessed.
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?: