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The purpose of this study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of orally administrated DWP05195 in healthy male volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DWP05195 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DWP05195 | Drug | tablets, oral administration, single and multiple administrations |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Safety & tolerability: Adverse events, vital signs, 12-Lead ECG, laboratory safety variables and physical examination | 72hr after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Cmax, tmax, AUC, and t½ in plasma / amount of drug, fraction, and CLr in urine Pharmacodynamics: Thermal NeuroSensory Analyser | 72 hr after drug administration |
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Inclusion Criteria:
Exclusion Criteria:
A subject with sign or symptoms or previously diagnosed disease of respiratory, cardiovascular, endocrinology, liver, kidney, gastrointestinal, hematology, neurology and psychology function or other significant diseases and history or suspicion of current drug abuse and alcohol abuse
A subject who had any allergic history to any drug (prescription drug or OTC medication etc.)
A subject who had received treatment with below listed drug within specified period prior to the first dose of study medication
A subject who had participated in any other clinical study within the last 12 weeks
A subject from whom over 400mL of blood was sampled(whole blood or plasma donation, etc.) within last 12 weeks
A Subject with the known evidence of the following infections or drug abuse
HIV, HBs, HCV
cannabinoid, opioid, amphetamine, cocaine, barbiturate, benzodiazepine
Smoker or smoking cessation within 1 month or ex-smoker with positive results by cotinine test
AST or ALT greater than 1.5 times the upper limit of reference range or QTc > 430 msec base on screening results
Blood pressure: SBP ≥ 140 mmHg, DBP ≤ 85 mmHg
A subject judged ineligible by the investigator to participate in this study for other reason containing clinical laboratory tests
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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 | South Korea |
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