Overview

This trial is active, not recruiting.

Condition healthy volunteers
Treatments udenafil, bosentan, udenafil/bosentan
Phase phase 1
Sponsor Dong-A Pharmaceutical Co., Ltd.
Collaborator Dong-A ST Co., Ltd.
Start date August 2013
End date November 2013
Trial size 30 participants
Trial identifier NCT01929213, DA8159_PAH_DI

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacokinetics study
Intervention model crossover assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
udenafil
Udenafil is administered
(Experimental)
bosentan
Bosentan is administered
(Experimental)
udenafil/bosentan
Udenafil and Bosentan are administered

Primary Outcomes

Measure
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
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

Eligibility Criteria

Male or female participants from 20 years up to 45 years old.

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

Additional Information

Official title 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
Principal investigator Min Soo Park
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by Dong-A Pharmaceutical Co., Ltd..