NCT02645890

Study to Compare the Safety and Pharmacokinetics of CKD-397

A Randomized, Open-label, Oral Single Dosing, Two-way Crossover Clinical Trial to Evaluate the Safety and Pharmacokinetic Profiles of CKD-397 in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: Male
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare the safety and pharmacokinetics profiles of CKD-397 in healthy male volunteers.

Detailed description

A randomized, open-label, oral single dosing, two-way crossover clinical trial to evaluate the safety and pharmacokinetic profiles of CKD-397 in healthy male subjects

Conditions

• Benign Prostatic Hyperplasia

Interventions

Type	Name	Description
DRUG	CKD-397	Arm A:Tamsulosin/ Tadalafil Fixed dose combination
DRUG	TD+TM	Arm B: Tamsulosin/ Tadalafil Coadministration

Timeline

• Start date: 2015-11-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2016-01-05
• Last updated: 2016-01-12

Locations

1 site across 1 country: South Korea