Erectile Dysfunction, Healthy Volunteers
Conditions
Keywords
DA-8159, Udenafil, Alcohol
Brief summary
This study is designed to to investigate the effects of alcohol on the pharmacokinetics of Udenafil tablet in healthy male volunteers
Interventions
DRUGUdenafil
200mg Single Oral Dose of
DIETARY_SUPPLEMENTAlcohol
Alcohol 39g / 240ml
Sponsors
Dong-A Pharmaceutical Co., Ltd.
Asan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 55 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (AUC and Cmax) | 48 Hours |
Countries
South Korea
Outcome results
None listed