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

Phase 1UnknownNCT01929213

Dong-A Pharmaceutical Co., Ltd.30 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

UdenafilDRUG

Udenafil is administered

BosentanDRUG

Bosentan is administered

Udenafil/BosentanDRUG

Udenafil and Bosentan are administered

Eligibility

Sex: ALLMin age: 20 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Severance Hospital Clinical Trial Center

Seoul, South Korea

Outcomes

Primary Outcomes

Udenafil, Bosentan C max,ss

Time frame: 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 AUC tau,ss

Data from ClinicalTrials.gov

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