Healthy
Conditions
Brief summary
The purpose of this study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of orally administrated DWP09031 in healthy male volunteers.
Interventions
DRUGDWP09031
DWP09031 50mg/100mg/400mg/200mg/800mg/1200mg/1600mg/2000mg single dosing
DRUGPlacebo
placebo comparator 50mg/100mg/400mg/200mg/800mg/1200mg/1600mg/2000mg single dosing
Sponsors
Daewoong Pharmaceutical Co. LTD.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy adult male subjects aged 20 to 45 years 2. The subject has Broca's index ≤ 20% 3. A Subject who was judged to be healthy by the investigator to participate in this study based on screening results (according to standard reference index updated recently) 4. A subject who provided written informed consent to participate in this study and cooperative with regard to compliance with study related constraints
Exclusion criteria
1. A subject with sign or symptoms or previously diagnosed disease of liver (viral hepatitis), digestive system, cardiovascular, kidney, respiratory, endocrinology, neurology, immune system, hematology, and psychology function or other significant diseases and history or suspicion of current drug abuse and alcohol abuse 2. A subject who shows vital signs with the number of systolic blood pressure of ≥141 mmHg or ≤89 mmHg, and the number of diastolic blood pressure of ≥91mmHg 3. A subject who shows the following result in clinical laboratory test: AST,ALT\>1.25 times of the upper limit of normal range PR ≥ 210 msec QRS ≥ 120 msec QT ≥ 500 msec QTcF ≥ 450 msec creatinine clearance ≤ 80mL/min 4. Subject who has taken other clinical or licensed medication from another clinical trial within an 90-day period prior to the first administration of the study medication (The last administration of the medication is considered as an end point of the previous clinical trial).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety&tolerability | -1d, 0 (predose), 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 h, 8d (post-study visit) | Adverse events, Physical exam, Vital sign, laboratory(CBC,chemistry,U/A etc) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics | 0 (predose), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 ,24 ,36, 48 h | Cmax, AUClast, AUCinf, t1/2, CL/F, Vd/F |
Countries
South Korea
Outcome results
None listed