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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01929213
• Other study ID #: DA8159_PAH_DI
• Status: Active, not recruiting
• Phase: Phase 1
• First received: August 22, 2013
• Last updated: January 7, 2014
• Start date: August 2013
• Est. completion date: February 2014

Study information

• Verified date: January 2014
• Source: Dong-A ST Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: February 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Udenafil
Udenafil is administered
• Bosentan
Bosentan is administered
• Udenafil/Bosentan
Udenafil and Bosentan are administered

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital Clinical Trial Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Dong-A Pharmaceutical Co., Ltd.	Dong-A ST Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No