Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06399068
Status:
COMPLETED
Last Update Posted:
2024-05-03
First Post:
2024-01-22
Brief Title:
Clinical Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-387 in Healthy Volunteers Under Fed Conditions
Sponsor:
Chong Kun Dang Pharmaceutical
Organization:
Chong Kun Dang Pharmaceutical
Study Overview
Official Title:
A Randomized Open-label Single Dose Crossover Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-387 in Healthy Volunteers Under Fed Conditions
Status:
COMPLETED
Status Verified Date:
2024-05
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 dose crossover study to evaluate the pharmacokinetic profiles and safety of CKD-387 in healthy volunteers under fed conditions
Detailed Description:
To 30 healthy subjects following treatments are administered dosing in each period and wash-out period is a minimum of 7 days 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?:
None