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

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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01929213

Enrollment

Registered

2013-08-27

Start date

2013-08-31

Completion date

2014-02-28

Last updated

2014-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

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

Interventions

DRUGUdenafil

Udenafil is administered

DRUGBosentan

Bosentan is administered

DRUGUdenafil/Bosentan

Udenafil and Bosentan are administered

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026