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

NCT01929213 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2014-01-09

No results posted yet for this study

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

Conditions

  • Healthy Volunteers

Interventions

DRUG

Udenafil

Udenafil is administered

DRUG

Bosentan

Bosentan is administered

DRUG

Udenafil/Bosentan

Udenafil and Bosentan are administered

Sponsors & Collaborators

  • Dong-A ST Co., Ltd.

    collaborator INDUSTRY

  • Dong-A Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Min Soo Park · Severance Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2013-11-30
Completion
2014-02-28

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01929213 on ClinicalTrials.gov