Phase I Study to Investigate the Alcohol Interaction of DA8159
Phase 1
Completed
- Conditions
- Healthy VolunteersErectile Dysfunction
- Interventions
- Dietary Supplement: Alcohol
- Registration Number
- NCT01241032
- Lead Sponsor
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 24
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
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Udenafil + Alcohol Alcohol Udenafil 200mg + Alcohol Udenafil Udenafil Udenafil 200mg Udenafil + Alcohol Udenafil Udenafil 200mg + Alcohol
- Primary Outcome Measures
Name Time Method Pharmacokinetics (AUC and Cmax) 48 Hours
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What is the mechanism of action of udenafil in the context of phosphodiesterase type 5 (PDE5) inhibition for erectile dysfunction?
How does alcohol consumption affect the pharmacokinetics of udenafil compared to other PDE5 inhibitors like sildenafil or tadalafil?
Are there specific biomarkers that correlate with udenafil's efficacy in treating erectile dysfunction when co-administered with alcohol?
What are the potential adverse events associated with udenafil-alcohol interactions in healthy male volunteers, and how are they managed?
How does udenafil's safety profile in combination with alcohol compare to other drugs in the same class for erectile dysfunction treatment?
Trial Locations
- Locations (1)
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Asan Medical Center🇰🇷Seoul, Korea, Republic of