Phase I Study to Investigate the Alcohol Interaction of D... | NCT01241032

Studies
Phase I Study to Investigate the Alcohol Interaction of DA8159

NCT01241032

Sponsor

Asan Medical Center

Status

Completed

Last Update Posted

Nov 16, 2010Estimated

Enrollment

24Actual

Phase

Phase 1

Conditions

Healthy Volunteers
Erectile Dysfunction

Interventions

Udenafil
Alcohol

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

Nov 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2006

Primary Completion Date

Feb 2007Actual

Completion Date

Not provided

First Submitted Date

Nov 15, 2010

First Submission Date that Met QC Criteria

Nov 15, 2010

First Posted Date

Nov 16, 2010Estimated

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

Nov 15, 2010

Last Update Posted Date

Nov 16, 2010Estimated

Name	Class
Dong-A Pharmaceutical 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

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

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Udenafil	Experimental	Udenafil 200mg	Drug: Udenafil
Udenafil + Alcohol	Active Comparator	Udenafil 200mg + Alcohol	Drug: Udenafil Dietary Supplement: Alcohol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Udenafil	Drug	200mg Single Oral Dose of	Udenafil Udenafil + Alcohol

Measure	Description	Time Frame
Pharmacokinetics (AUC and Cmax)		48 Hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult males aged 19 to 55 years at screening.
Subjects with body weight ≥ 55 kg and within ±20% of the ideal body weight : Ideal body weight = (height [cm] - 100)x0.9.
Subjects who have received and understood completely the information regarding the current study and given written informed consents to voluntarily participate in the study and followed all instructions specified in the protocol.

Exclusion Criteria:

Subjects with the test results of QTc > 430 ms or non-sinus cardiac rhythm by ECG analysis.
Subjects with hypotension or hypertension.
Subjects who have drunken habitually (exceeding 21 units/week, 1 unit = 10 g of pure alcohol) or who are unable to abstain from drinking during the study period from 2 days prior to the first administration of investigational product and during this study.
Subjects deemed ineligible by investigator based on other reasons, including abnormal laboratory values or diseases.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kyun-Seop Bae, M.D., Ph.D.	Asan Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Asan Medical Center		Seoul			South Korea

Label	URL
Clinical Research Center, Asan Medical Center	View source

Condition Browse Module

MeSH Terms

ID	Term
D007172	Erectile Dysfunction

Ancestor Terms

ID	Term
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D012735	Sexual Dysfunction, Physiological

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Term
C419664	udenafil
D000431	Ethanol

ID	Term
D000438	Alcohols
D009930	Organic Chemicals