Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2025-12-26 @ 11:58 AM
Study NCT ID:
NCT01341392
Status:
COMPLETED
Last Update Posted:
2011-08-15
First Post:
2011-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drug-drug Interaction Study(CKD-501, Amlodipine)
Sponsor:
Chong Kun Dang Pharmaceutical
Organization:
Study Overview
Official Title:
A Randomized, Open-label, Multiple Dose, Three-treatment, Three-period, Six-sequence Crossover Clinical Trial to Investigate the Pharmacokinetic Drug Interaction Between CKD-501 and Amlodipine After Oral Administration in Healthy Male Volunteers
Status:
COMPLETED
Status Verified Date:
2011-08
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:
The purpose of this study is to assess the pharmacokinetic drug interaction between CKD-501 and amlodipine after oral administration in healthy male volunteers.
Detailed Description:
Volunteers doses three times over the period of CKD-501 0.5mg or Amlodipine 10mg alone/co-administrate, repeated doses are 10 days.
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?: