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

• Status: Unknown status
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Dong-A Pharmaceutical Co., Ltd.
• Collaborator: Dong-A ST Co., Ltd.
• Treatments: Bosentan; Udenafil

Criteria

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