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Completed

NCT Number: NCT01241032

Phase I Study to Investigate the Alcohol Interaction of DA8159

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

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Key information

Conditions

Healthy Volunteers Erectile Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

19 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Asan Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Udenafil

Drug

200mg Single Oral Dose of

Alcohol

Dietary Supplement

Alcohol 39g / 240ml

Primary outcomes

  1. Pharmacokinetics (AUC and Cmax)

    Time frame: 48 Hours

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Collaborators

  • Dong-A Pharmaceutical Co., Ltd.

Registry information

Official study title

A Randomized, Open, Crossover Clinical Study to Investigate the Effects of Alcohol on the Pharmacokinetics of Udenafil Tablet in Healthy Male Volunteers

Acronym: DA8159_DIA_I

Important dates

Study start
2006
Primary completion
2007
First posted
Nov 16, 2010
Registry last updated
Nov 16, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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