Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2025-12-26 @ 3:57 AM
Study NCT ID:
NCT02247518
Status:
COMPLETED
Last Update Posted:
2015-08-20
First Post:
2014-09-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CKD-397 Drug-drug Interaction Study (A)
Sponsor:
Chong Kun Dang Pharmaceutical
Organization:
Study Overview
Official Title:
A Randomized, Open-label, Multiple Dosing, 2-way Crossover Study to Evaluate the Pharmacokinetic Effect of Tamsulosin on Tadalafil in Healthy Male Volunteers
Status:
COMPLETED
Status Verified Date:
2015-08
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:
CKD-397DDI(A)
Brief Summary:
The purpose of this study is to investigate to effect of tamsulosin on the pharmacokinetic properties of tadalafil
Detailed Description:
This study is a randomized, open-label, mutiple dosing, 2-way crossover design to evaluate the pharmacokinetic effect of tamsulosin(0.2mg) on tadalafil(5mg) in healthy male subjects. Subjects will receive repeated dose of tadalafil (5mg\*1t/day) or tadalafil (5mg\*1t/day) / tamsulosin (0.2mg\*1t/day) for 5days. Each treatment period was separated by a washout period of at least 10 days.
Each period of study will enroll 8 healthy male subjects. Blood samples for pharmacokinetic analysis will be taken at regular intervals after dosing. Safety will be assessed by measurement of blood pressure, heart rate, safety laboratory data, and review of adverse events.
Each period of study will enroll 8 healthy male subjects. Blood samples for pharmacokinetic analysis will be taken at regular intervals after dosing. Safety will be assessed by measurement of blood pressure, heart rate, safety laboratory data, and review of adverse events.
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?: