None listed
Conditions
Interventions
Drug : SK3530 100 mg or placebo was taken orally 3 hours the administration of tamsulosin 0.2 mg.
Sponsors
Seoul National University Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Healthy male adults aged 20 ~ 50 at screening 2. Weight = 55 kg and ±20% of ideal body weight ? ideal body weight - (height cm - 100) x 0.9 3. Signed the informed consent after understanding explanation of the clinical trial
Exclusion criteria
Exclusion criteria: 1. Clinically significant history or current hypersensitivity to SK3530, tamsulosin, or other drug (aspirin, antibiotics) 2. Past or current medical history for the diseases in hepatobiliary, renal, nervous, respiratory, endocrinologic, hemato-oncologic, psycologic, ophthalmic or cardiovascular systems including disorders in blood coagulation3. Past medical history of gastrointestinal disease or sugery which can affect the absorption of the investigational drug (except for an simple appendectomy, hernia repair surgery) 4. Clinical laboratory test at screening ? AST, ALT > (upper limit of normal reference range)x 1.25 5. Vital signs in supine position at screening ? low blood pressures (SBP = 90 mmHg or DBP = 60 mmHg) or high blood pressures (SBP = 140 mmHg or DBP = 90 mmHg) 6. Decreased blood pressures over 20 mmHg of SBP or 10 mmHg of DBP at 2 and 4 minutes after standing from supine position 7. QTc interval over 430 ms 8. A history of drug abuse or a positive result on urine drug testing 9. Administered any prescription drug or herbal medicine within 2 weeks prior to the first administration day, or administered any over-the-counter drug or vitamin agent within 1 week before the first administration (however, such a subject can be included when investigators so determined after considering other conditions) 10. Participated in another clinical study within 2 months prior to first administration 11. Donated whole blood within 2 months prior to the first administration, apheresis within 1 month prior to the first administration 12. Chronic alcohol consumer (over 21 units/week, 1 unit = 10 g of pure alcohol) or inable to stop drinking during the study 13. Heavy smoker (average : 10 pieces of cigarettes per day) 14. Anyone taking food with graphfruits or caffein, drinking alcohol, or smoking from 3 days prior to the first administration of each period (-9 d, 6 d) to the day of dischage (2 d, 16 d) 15. Determined to be inappropriate for the study based on laboratory tests or other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SBP and DBP at supine and standing postion | — |
Secondary
| Measure | Time frame |
|---|---|
| Pulse rate at supine and standing postion | — |
Countries
Korea, Republic of
Contacts
Public ContactNamyi Gu
Seoul National University Hospital
Outcome results
None listed