NCT01241032

Brief Summary

This study is designed to to investigate the effects of alcohol on the pharmacokinetics of Udenafil tablet in healthy male volunteers

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

November 15, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 16, 2010

Completed
Last Updated

November 16, 2010

Status Verified

November 1, 2010

Enrollment Period

8 months

First QC Date

November 15, 2010

Last Update Submit

November 15, 2010

Conditions

Healthy VolunteersErectile Dysfunction

Keywords

DA-8159UdenafilAlcohol

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics (AUC and Cmax)

    48 Hours

Study Arms (2)

Udenafil

EXPERIMENTAL

Udenafil 200mg

Drug: Udenafil

Udenafil + Alcohol

ACTIVE COMPARATOR

Udenafil 200mg + Alcohol

Drug: UdenafilDietary Supplement: Alcohol

Interventions

UdenafilDRUG

200mg Single Oral Dose of

UdenafilUdenafil + Alcohol
AlcoholDIETARY_SUPPLEMENT

Alcohol 39g / 240ml

Udenafil + Alcohol

Eligibility Criteria

Age19 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

Related Links

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

udenafilEthanol

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • Kyun-Seop Bae, M.D., Ph.D.

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 15, 2010

First Posted

November 16, 2010

Study Start

June 1, 2006

Primary Completion

February 1, 2007

Last Updated

November 16, 2010

Record last verified: 2010-11

Locations

KR(1)