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

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

Inclusion Criteria:

• healthy volunteers between the ages of 20 to 45 years old within the range of BMI between 18.5 and 25(Body Mass Index)
• having neither congenital/chronic diseases nor pathological symptoms/findings as results of medical examination
• doctor determines to be suitable as subjects within 4 weeks ago before administration

Exclusion Criteria:

• Hypersensitivity(or history of hypersensitivity) to Udenafil, Bosentan and PDE5 inhibitors
• Active Liver Diseases or exceed 1.25 times the normal range of AST, ALT
• Gastrointestinal diseases or surgeries that affect absorption of drug
• Excessive drinking(exceed 210g/week) and excessive caffeine(exceed 5cups/day)
• Smoking over 10 cigarettes per day
• pregnant or nursing female volunteers