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CompletedNCT01241032DA8159_DIA_IUpdated Nov 16, 2010

Phase I Study to Investigate the Alcohol Interaction of DA8159

A Phase 1 interventional study of Udenafil and Alcohol in Healthy Volunteers and Erectile Dysfunction, sponsored by Asan Medical Center. Completed at 1 site in South Korea. Open to male participants aged 19 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-11-16.

Sponsored by Asan Medical Center · Phase 1, Interventional, and Supportive care

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
19 Years to 55 Years
Sex
Male
01

Study summary

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

02

Conditions studied

  • Healthy Volunteers
  • Erectile Dysfunction

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Keywords

  • DA-8159
  • Udenafil
  • Alcohol
03

In context

Erectile Dysfunction

698 studies on the registry are indexed under Erectile Dysfunction; 116 are open to participants now.

This study's enrollment of 24 is below the median of 72 across 552 interventional studies indexed under Erectile Dysfunction.

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Lead sponsor

Asan Medical Center is the lead sponsor of 577 studies on the registry; 73 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Udenafil

    Udenafil 200mg

    Drug: Udenafil

  • Active comparator
    Udenafil + Alcohol

    Udenafil 200mg + Alcohol

    Drug: Udenafil · Dietary Supplement: Alcohol

Interventions

  • DrugUdenafil

    200mg Single Oral Dose of

  • Dietary supplementAlcohol

    Alcohol 39g / 240ml

06

What researchers measure

Primary outcomes

  1. Pharmacokinetics (AUC and Cmax)

    Time frame: 48 Hours

07

Study locations

1 site
  • Asan Medical Center
    Seoul, South Korea
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 16, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01241032
Lead sponsor
Asan Medical Center
Collaborators
Dong-A Pharmaceutical Co., Ltd.
First posted
Nov 16, 2010
Start date
Jun 2006
Primary completion
Feb 2007
Last update
Nov 16, 2010

Study contacts

Kyun-Seop Bae, M.D., Ph.D.
principal investigator · Asan Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2010. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Udenafil · Ethanol

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