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

Dong-A Pharmaceutical

Status and phase: Unknown; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Udenafil/Bosentan; Drug: Udenafil; Drug: Bosentan

Study type: Interventional

Funder types: Industry

Identifiers

NCT01929213

DA8159_PAH_DI

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Udenafil

Experimental group

Treatment:

Drug: Udenafil

Bosentan

Experimental group

Treatment:

Drug: Bosentan

Udenafil/Bosentan

Experimental group

Treatment:

Drug: Udenafil/Bosentan