NCT01929213

Clinical Trial to Investigate the Pharmacokinetic Drug Interaction Between Udenafil and Bosentan After Oral Administration

A Randomized, Open-label, Multiple Dose, Three-treatment, Three-period, Six-sequence Williams Design to Investigate the Pharmacokinetic Drug Interaction Between Udenafil and Bosentan After Oral Administration in Healthy Volunteers

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Dong-A Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study is designed to investigate the pharmacokinetic drug interaction and safety after oral administration of Udenafil(DA-8159) and Bosentan in healthy volunteers. Design: Randomized, open-label, multiple-dose, three-treatment, three-period, six-sequence, Williams design Investigational Product: Udenafil, Bosentan

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Udenafil	Udenafil is administered
DRUG	Bosentan	Bosentan is administered
DRUG	Udenafil/Bosentan	Udenafil and Bosentan are administered

Timeline

• Start date: 2013-08-01
• Primary completion: 2013-11-01
• Completion: 2014-02-01
• First posted: 2013-08-27
• Last updated: 2014-01-09

Locations

1 site across 1 country: South Korea