Clinical Trial to Investigate the Pharmacokinetic Drug In... | NCT01929213

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

NCT01929213

Sponsor

Dong-A Pharmaceutical Co., Ltd.

Status

Unknown status

Last Update Posted

Jan 9, 2014Estimated

Enrollment

30Estimated

Phase

Phase 1

Conditions

Healthy Volunteers

Interventions

Udenafil
Bosentan
Udenafil/Bosentan

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2013

Primary Completion Date

Nov 2013Actual

Completion Date

Feb 2014Estimated

First Submitted Date

Aug 22, 2013

First Submission Date that Met QC Criteria

Aug 22, 2013

First Posted Date

Aug 27, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 7, 2014

Last Update Posted Date

Jan 9, 2014Estimated

Name	Class
Dong-A ST Co., Ltd.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Udenafil	Experimental	Drug: Udenafil
Bosentan	Experimental	Drug: Bosentan
Udenafil/Bosentan	Experimental	Drug: Udenafil/Bosentan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Udenafil	Drug	Udenafil is administered	Udenafil
Bosentan

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Min Soo Park	Severance Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Severance Hospital Clinical Trial Center		Seoul			South Korea

Intervention Browse Module

MeSH Terms

ID	Term
C419664	udenafil
D000077300	Bosentan

Ancestor Terms

ID	Term
D000096926	Benzenesulfonamides
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided