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change development strategy
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The purpose of this study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of orally administrated DWP09031 in healthy male volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DWP09031 | Experimental | DWP09031 50mg/100mg/400mg/200mg/800mg/1200mg/1600mg/2000mg single dosing |
|
| Placebo | Placebo Comparator | placebo comparator 50mg/100mg/400mg/200mg/800mg/1200mg/1600mg/2000mg single dosing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DWP09031 | Drug | DWP09031 50mg/100mg/400mg/200mg/800mg/1200mg/1600mg/2000mg single dosing |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety&tolerability | Adverse events, Physical exam, Vital sign, laboratory(CBC,chemistry,U/A etc) | -1d, 0 (predose), 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 h, 8d (post-study visit) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics | Cmax, AUClast, AUCinf, t1/2, CL/F, Vd/F | 0 (predose), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 ,24 ,36, 48 h |
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Inclusion Criteria:
Exclusion Criteria:
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
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
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
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).
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| Name | Affiliation | Role |
|---|---|---|
| Jae-Gook Shin, Professor | BUSAN PAIK HOSPITAL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inje University College of Medicine Busan Paik Hospital | Busan | Busanjin-gu | 614-735 | South Korea |
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| Placebo |
| Drug |
placebo comparator 50mg/100mg/400mg/200mg/800mg/1200mg/1600mg/2000mg single dosing |
|