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

Phase 1

• Conditions: Healthy Volunteers
• Interventions: Drug: Udenafil/Bosentan; Drug: Udenafil; Drug: Bosentan

• Registration Number: NCT01929213
• Lead Sponsor: Dong-A Pharmaceutical Co., Ltd.

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-22
• Study First Submitted QC: 2013-08-22
• Study First Posted: 2013-08-27
• Primary Completion: 2013-11
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-07
• Last Update Posted: 2014-01-09
• Study Completion: 2014-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Udenafil/Bosentan	Udenafil/Bosentan	-
Udenafil	Udenafil	-
Bosentan	Bosentan	-

Primary Outcome Measures

Name	Time	Method
Udenafil, Bosentan AUC tau,ss	Blood gathering point: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12h of D1, D15, D29(if Udenafil adminstrated alone), 0 h of D7, D21, D35, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36 h of D8, D22, D36
Udenafil, Bosentan C max,ss	Blood gathering point: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12h of D1, D15, D29(if Udenafil adminstrated alone), 0 h of D7, D21, D35, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36 h of D8, D22, D36

Trial Locations

Locations (1)

Severance Hospital Clinical Trial Center; 🇰🇷 Seoul, Korea, Republic of