Recruitment

Recruitment Status
Unknown status

Inclusion Criterias

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
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
healthy volunteers between the ages of 20 to 45 years old within the range of BMI between 18.5 and 25(Body Mass Index)

Exclusion Criterias

Gastrointestinal diseases or surgeries that affect absorption of drug
pregnant or nursing female volunteers
Hypersensitivity(or history of hypersensitivity) to Udenafil, Bosentan and PDE5 inhibitors
...
Gastrointestinal diseases or surgeries that affect absorption of drug
pregnant or nursing female volunteers
Hypersensitivity(or history of hypersensitivity) to Udenafil, Bosentan and PDE5 inhibitors
Excessive drinking(exceed 210g/week) and excessive caffeine(exceed 5cups/day)
Smoking over 10 cigarettes per day
Active Liver Diseases or exceed 1.25 times the normal range of AST, ALT

Summary

Conditions
Healthy Volunteers
Type
Interventional
Phase
Phase 1
Design
  • Allocation: Randomized
  • Intervention Model: Crossover Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 20 years and 45 years
Gender
Both males and females

Inclusion Criterias

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
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
healthy volunteers between the ages of 20 to 45 years old within the range of BMI between 18.5 and 25(Body Mass Index)

Exclusion Criterias

Gastrointestinal diseases or surgeries that affect absorption of drug
pregnant or nursing female volunteers
Hypersensitivity(or history of hypersensitivity) to Udenafil, Bosentan and PDE5 inhibitors
...
Gastrointestinal diseases or surgeries that affect absorption of drug
pregnant or nursing female volunteers
Hypersensitivity(or history of hypersensitivity) to Udenafil, Bosentan and PDE5 inhibitors
Excessive drinking(exceed 210g/week) and excessive caffeine(exceed 5cups/day)
Smoking over 10 cigarettes per day
Active Liver Diseases or exceed 1.25 times the normal range of AST, ALT

Locations

Seoul
Seoul

Tracking Information

NCT #
NCT01929213
Collaborators
Dong-A ST Co., Ltd.
Investigators
  • Principal Investigator: Min Soo Park Severance Hospital
  • Min Soo Park Severance Hospital