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

This study has been completed.
Sponsor:
Collaborator:
Dong-A Pharmaceutical Co., Ltd.
Information provided by:
Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01241032
First received: November 15, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted
  Purpose

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


Condition Intervention Phase
Healthy Volunteers
Erectile Dysfunction
Drug: Udenafil
Dietary Supplement: Alcohol
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Pharmacokinetics (AUC and Cmax) [ Time Frame: 48 Hours ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: June 2006
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   19 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01241032

Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Asan Medical Center
Dong-A Pharmaceutical Co., Ltd.
Investigators
Principal Investigator: Kyun-Seop Bae, M.D., Ph.D. Asan Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: Clinical Development Team1, Dong-A Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01241032     History of Changes
Other Study ID Numbers: 2006-0086
Study First Received: November 15, 2010
Last Updated: November 15, 2010
Health Authority: Korea: Food and Drug Administration

Keywords provided by Asan Medical Center:
DA-8159
Udenafil
Alcohol

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Ethanol
Udenafil
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 15, 2014