None listed
Conditions
Interventions
Drug : IP : DW2008S
Oral Medication
Through safety evaluation of each dose group, next dose group(ascending dose) initiation will be determined.
(ex. Group A ->
safety evaluation ->
Group B ->
Group C ->
Group D)
<
Single Administration>
- Group A,B,C and D / A : 100mg / B : 200mg / C : 400mg / D:800mg
- Single administration, Hospitalization for 3 days per each group
- Final Observation date : 14 days after administration
- 8 subject
Multiple Administration>
- Group E, F, G and H / E : 100mg / F : 200mg / G : 400mg / H : 800mg
- Administration for 8 days per each group, (Hospitalization(2 nights 3 days)->
Out-patient(5 days)->
Hospitalization(2 nights 3 days))
- Final Observation date : 21 days after administration
- 8 subjects/each group (6 subjects Test Drug / 2 subjects Placebo)
Sponsors
Dongwha Pharmaceutical
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. A healthy male adult within the range of 19 to 45 years old at the time of screening 2. BMI=18.0~27.0kg/m2, one with weight range of 55kg to 90kg (BMI= kg/(m)2) 3. Subject should not have congenital/chronic disease or pathological symptoms/findings 4. Subject judged to be eligible by clinical tests such as hematology test, blood chemistry test, serum electrolyte test, urine test, Urine Microscopy urine test, serology test performed according to the study protocol. 5. One who understood completely about this study after the detailed explanation is given, decided to volunteer and gave written informed consent to participate in study in compliance with the requirement of the entire protocol
Exclusion criteria
Exclusion criteria: 1. one with clinically significant disease in liver, kidney, nerve system, respiratory system, endocrine system, blood, tumor, urinary system, cardiovascular system, mental disease or with medical history 2. one with disorders of micturition include benign prostatic hyperplasia 3. one who is allergic or has clinically significant allergic history to drug(Aspirin, Antibiotics, etc.), and investigational product. 4. One who have indicated the AST or ALT values are 1.5 times higher than the normal range upper limit in screening test. 5. One who has included blood pressure in the vital signs measured in the seated position after a rest for 3 min or more, systolic pressure < 100 mmHg or >160 mmHg 6. One who has included blood pressure in the vital signs measured in the seated position after a rest for 3 min or more, diastolic pressure < 50 mmHg or >100 mmHg 7. One who has drug abuse history within 2 weeks prior to the first administration / One who is positive response in urine toxic screening for drug abuse 8.A person who takes prescription drug or Chinese medicine within 2 weeks before Investigational Product administration and who takes OTC or vitamins within 10 days before Investigational Product administration. (but, clinical study may be conducted when different conditions are appropriate depending on the PI’s opinion.) 9. A person who is currently participating in a clinical study or 6 months has not passed since the final administration of another clinical study. 10. Donation of a unit of blood within two months, or of blood components within one month, or receipt of blood transfusion within one month before the first administration of the study drug. 11. One who continue to drink alcohol (21 units/week over, 1 unit = 10g of pure alcohol) or stop drinking during the clinical study. 12. A smoker on average daily, over 10 cigarettes, in the past 3 months or stop smoking during the clinical study. 13. One who eats grapefruit/caffein products from 24 hours prior to hospitalization during study drug administration. 14. One who plan pregnancy or don't use reliable methods of birth-control(one's own and partner's sterilization operation, partner's contraceptive device, barrier contraception or combined using of condom) 15. Otherwise judged by the investigator to be inappropriate for inclusion in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (Part I: AUClast, AUCinf, Cmax, Tmax, t1/2, CL/F, Vz/F; AUCinf, AUC0-24, AUCt, Cmax, Cmax,ss, Cmin,ss, Cav,ss, Tmax, Tmax,ss, t1/2, t1/2,ss, PTF, R, CL/F, CLss/F, Vz/F, Vss/F) | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event including subjective or objective sign;Vital sign, Physical exam, Lab test, EKG | — |
Countries
Korea, Republic of
Contacts
Public ContactJinSoo Park
Dongwha Pharmaceutical
Outcome results
None listed