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

January 7, 2014 updated by: Dong-A Pharmaceutical Co., Ltd.

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bosentan
Drug: Bosentan
Bosentan is administered
Experimental: Udenafil
Drug: Udenafil
Udenafil is administered
Experimental: Udenafil/Bosentan
Drug: Udenafil/Bosentan
Udenafil and Bosentan are administered

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dong-A Pharmaceutical Co., Ltd.

Collaborators

Dong-A ST Co., Ltd.

Investigators

  • Principal Investigator: Min Soo Park, Severance Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

November 1, 2013

Study Completion (Anticipated)

February 1, 2014

Study Registration Dates

First Submitted

August 22, 2013

First Submitted That Met QC Criteria

August 22, 2013

First Posted (Estimate)

August 27, 2013

Study Record Updates

Last Update Posted (Estimate)

January 9, 2014

Last Update Submitted That Met QC Criteria

January 7, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DA8159_PAH_DI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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