Ignite Creation Date:
2025-12-24 @ 5:28 PM
Ignite Modification Date:
2026-02-21 @ 8:27 AM
Study NCT ID:
NCT02565368
Status:
COMPLETED
Last Update Posted:
2015-10-01
First Post:
2015-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Study to Compare the Pharmacokinetic Characteristics of CKD-395 0.5/1000 mg in Healthy Male Volunteers
Sponsor:
Chong Kun Dang Pharmaceutical
Organization:
Study Overview
Official Title:
A Randomized, Open-label, Single Dose, 2-way Crossover Study to Compare the Pharmacokinetic Characteristics of CKD-395 0.5/1000 mg in Healthy Male Volunteers
Status:
COMPLETED
Status Verified Date:
2015-09
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 is a randomized, open-label, single dose, 2-way crossover study to compare the pharmacokinetic characteristics of CKD-395 0.5/1000 mg in healthy male volunteers.
Detailed Description:
To healthy male subjects of twenty six(26), following treatments are administered dosing in each period fed condition(high fat meals) and wash-out period is a minimum of 7 days.
Treatment A(Reference Drug): DuvieTM Tab. 0.5mg 1T + Glicophage XR Tab. 1000mg 1T Treatment B(Test Drug): CKD-395 0.5/1000mg Tab. 1T Pharmacokinetic blood samples are collected up to 48hrs. Safety and pharmacokinetic are assessed.
Treatment A(Reference Drug): DuvieTM Tab. 0.5mg 1T + Glicophage XR Tab. 1000mg 1T Treatment B(Test Drug): CKD-395 0.5/1000mg Tab. 1T Pharmacokinetic blood samples are collected up to 48hrs. Safety and pharmacokinetic are assessed.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: