NCT02247518

CKD-397 Drug-drug Interaction Study (A)

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: Male
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Cialis Tab. 5mg
DRUG	Harnal-D Cap. 0.2mg

Timeline

• Start date: 2014-09-01
• Primary completion: 2014-10-01
• Completion: 2014-12-01
• First posted: 2014-09-25
• Last updated: 2015-08-20

Locations

1 site across 1 country: South Korea