Clinical Trial to Investigate the Pharmacokinetic Drug Interaction Between Udenafil and Bosentan After Oral Administration
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
1 other identifier
interventional
30
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy-volunteers
Started Aug 2013
Typical duration for phase_1 healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2013
CompletedFirst Submitted
Initial submission to the registry
August 22, 2013
CompletedFirst Posted
Study publicly available on registry
August 27, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedJanuary 9, 2014
January 1, 2014
3 months
August 22, 2013
January 7, 2014
Conditions
Outcome Measures
Primary Outcomes (2)
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
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
Study Arms (3)
Udenafil
EXPERIMENTALBosentan
EXPERIMENTALUdenafil/Bosentan
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dong-A Pharmaceutical Co., Ltd.lead
- Dong-A ST Co., Ltd.collaborator
Study Sites (1)
Severance Hospital Clinical Trial Center
Seoul, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Min Soo Park
Severance Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2013
First Posted
August 27, 2013
Study Start
August 1, 2013
Primary Completion
November 1, 2013
Study Completion
February 1, 2014
Last Updated
January 9, 2014
Record last verified: 2014-01