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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study in Healthy Men to Test How Bosentan Influences the Amount of Nerandomilast in the Blood

NCT07081932

Healthy

COMPLETED PHASE1

A Clinical Trial to Evaluate Drug-drug Interactions and Safety Between "BR1015-1" and "BR1015-2" in Healthy Volunteers

NCT05097794

Hypertension

COMPLETED PHASE1

A Phase 1 Drug Drug Interaction Clinical Trial of C1-R215 and C2-R215 in Healthy Male Volunteers

NCT03005340

Healthy

UNKNOWN PHASE1

Drug Interaction and Safety Between Valsartan and Rosuvastatin in Healthy Male Volunteers

NCT01918709

Hypertension, Hyperlipidemia

COMPLETED PHASE1

Study to Evaluate the Pharmacokinetic Interaction and Safety After Multiple Oral Doses of Fimasartan/Amlodipine and Rosuvastatin in Healthy Male Subjects

NCT02397538

Hypertension

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Volunteers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Udenafil

Group Type EXPERIMENTAL

Udenafil

Intervention Type DRUG

Udenafil is administered

Bosentan

Group Type EXPERIMENTAL

Bosentan

Intervention Type DRUG

Bosentan is administered

Udenafil/Bosentan

Group Type EXPERIMENTAL

Udenafil/Bosentan

Intervention Type DRUG

Udenafil and Bosentan are administered

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Udenafil

Udenafil is administered

Intervention Type DRUG

Bosentan

Bosentan is administered

Intervention Type DRUG

Udenafil/Bosentan

Udenafil and Bosentan are administered

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes