None listed
Conditions
Interventions
Drug : Single oral adminisration of udenafil 100 mg (1 tablet)
Arm 1: healthy young males (aged 19-45)
Arm 2: healthy elderly males (aged 65-80)
Sponsors
Dong-A Pharm
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - Healthy young male volunteers, aged 19-45 years, and healthy elderly male volunteers, aged 65-80 years, were within 15% and 20% of their standard body weight according to the Broca’s formula - Subjects who judged to be healthy based on the results of a detailed clinical examination
Exclusion criteria
Exclusion criteria: 1) a history of allergy 2) a history of hypersensitivity for study drug ingredients 3) administration of inducers or inhibitors of drug-metabolizing enzymes within 1 month 4) a history of cardiovascular, immune, blood, cerebrovascular, respiratory, digestive system, liver and renal disease 5) a history of gastrectomy except appendectomy 6) subjects who had experienced alcohol and drug abuse or smokers 7) a diet containing foods known to affect the absorption, distribution, metabolism, and excretion of the study drugs (e.g., grapefruit juice) 8) a history of participation in another clinical study within 90 days 9) a whole-blood donation of 200mL within 4 weeks or 400mL within 12 weeks prior to study initiation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax, AUC, Tmax, half-life, CL/F, Vdss/F | — |
Secondary
| Measure | Time frame |
|---|---|
| Cmax, AUC, Tmax, half-life of DA-8164 (metabolite) | — |
Countries
Korea, Republic of
Contacts
Public ContactHyangki Choi
Inje University
Outcome results
None listed