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The purpose of this study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of orally administrated DWP10292 in healthy male volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Drug: Placebo tablets, oral administration, single administrations Arms: Placebo |
|
| DWP10292 | Experimental | Drug: DWP10292 tablets, oral administration, single administrations Arms: DWP10292 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DWP10292 | Drug | Drug: DWP10292 tablets, oral administration, single administration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of Pharmacokinetics | Cmax, AUClast, AUCinf, Tmax, t1/2, CL/F | 0 (predose), 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 16, 24 (2d 0h), 36, 48 (3d 0h), 60, 72 (4d 0h), 96 h(5d 0h) and Post study visit 216h (10d 0h) |
| Measure | Description | Time Frame |
|---|---|---|
| Safety&tolerability | Adverse events, Physical exam, Vital sign, laboratory(CBC,chemistry,U/A etc) | 0 (predose), 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 16, 24 (2d 0h), 36, 48 (3d 0h), 60, 72 (4d 0h), 96 h(5d 0h) Post study visit 216h (10d 0h) |
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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 ≥140 mmHg or ≤100 mmHg, and the number of diastolic blood pressure of ≥90mmHg or ≤60mmHg
A subject who shows the following result in clinical laboratory test:
A subject from whom over 400mL of blood was sampled(whole blood or plasma donation, etc.) within last 8 weeks
Subject who has taken other clinical or licensed medication from another clinical trial within an 8-week 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).
Subject who smokes an average of 10 cigarettes/day and is unable to quit smoking during the clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Kyung-Sang Yu | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | Korea | South Korea | |||
| Seoul National University Hospital |
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| Placebo |
| Drug |
Placebo tablets, oral administration, single administrations |
|
| Seoul |
| South Korea |