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Phase I Study to Investigate the Alcohol Interaction of DA8159 (DA8159_DIA_I)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01241032
Recruitment Status : Completed
First Posted : November 16, 2010
Last Update Posted : November 16, 2010
Dong-A Pharmaceutical Co., Ltd.
Information provided by:
Asan Medical Center

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

Condition or disease Intervention/treatment Phase
Healthy Volunteers Erectile Dysfunction Drug: Udenafil Dietary Supplement: Alcohol Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Randomized, Open, Crossover Clinical Study to Investigate the Effects of Alcohol on the Pharmacokinetics of Udenafil Tablet in Healthy Male Volunteers
Study Start Date : June 2006
Actual Primary Completion Date : February 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Ethanol

Arm Intervention/treatment
Experimental: Udenafil
Udenafil 200mg
Drug: Udenafil
200mg Single Oral Dose of

Active Comparator: Udenafil + Alcohol
Udenafil 200mg + Alcohol
Drug: Udenafil
200mg Single Oral Dose of

Dietary Supplement: Alcohol
Alcohol 39g / 240ml

Primary Outcome Measures :
  1. Pharmacokinetics (AUC and Cmax) [ Time Frame: 48 Hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01241032

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Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Asan Medical Center
Dong-A Pharmaceutical Co., Ltd.
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Principal Investigator: Kyun-Seop Bae, M.D., Ph.D. Asan Medical Center
Additional Information:
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Responsible Party: Clinical Development Team1, Dong-A Pharmaceutical Co., Ltd. Identifier: NCT01241032    
Other Study ID Numbers: 2006-0086
First Posted: November 16, 2010    Key Record Dates
Last Update Posted: November 16, 2010
Last Verified: November 2010
Keywords provided by Asan Medical Center:
Additional relevant MeSH terms:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Mental Disorders
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action