NCT02352311

Safety and Pharmacokinetic Characteristics of DKF-313

A Randomized, Open-label, Single-dose, 2-treatment, 2-way, 2-period Crossover Study to Evaluate the Safety and the Pharmacokinetic Characteristics of DKF-313 in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Dongkook Pharmaceutical Co., Ltd. · Industry
• Sex: Male
• Age: 19 Years – 29 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, open-label, single-dose, 2-treatment, 2-way, 2-period crossover study to evaluate the safety and the pharmacokinetic characteristics of DKF-313 (dutasteride and tadalafil) in healthy male volunteers.

Detailed description

This study is conducted to evaluate the pharmacokinetics of DKF-313 (dutasteride and tadalafil) comparing with the concomitant administration of AVODART and CIALIS in healthy male volunteers.

Conditions

• Benign Prostate Hyperplasia
• Healthy

Interventions

Type	Name	Description
DRUG	DKF-313	Combination of dutasteride 0.5 mg and tadalafil 5 mg
DRUG	AVODART	Dutasteride 0.5 mg
DRUG	CIALIS	Tadalafil 5 mg

Timeline

• Start date: 2015-01-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2015-02-02
• Last updated: 2021-07-06

Locations

1 site across 1 country: South Korea