Phase I Study to Investigate the Alcohol Interaction of DA8159

Healthy Volunteers Clinical Trial

— DA8159_DIA_I  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01241032
• Other study ID #: 2006-0086
• Status: Completed
• Phase: Phase 1
• First received: November 15, 2010
• Last updated: November 15, 2010
• Start date: June 2006

Study information

• Verified date: November 2010
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. primary completion date: February 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Erectile Dysfunction
• Healthy Volunteers

Intervention

Drug:
• Udenafil
200mg Single Oral Dose of

Dietary Supplement:
• Alcohol
Alcohol 39g / 240ml

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Asan Medical Center	Dong-A Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (AUC and Cmax)		48 Hours	No

External Links

•   Clinical Research Center, Asan Medical Center