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| Name | Class |
|---|---|
| Asan Medical Center | OTHER |
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This study is designed to evaluate dose-proportionality of Dilatrend SR 8mg, 16mg, 32mg, 64mg, 128mg in healthy male volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dilatrend SR capsule 8mg | Experimental |
| |
| Dilatrend SR capsule 16mg | Experimental |
| |
| Dilatrend SR capsule 32mg | Experimental |
| |
| Dilatrend SR capsule 64mg | Experimental |
| |
| Dilatrend SR capsule 128mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dilatrend SR capsule | Drug | single oral administration in period 1 or 2, 3 for each sequential group. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-proportionality | AUClast | 0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h |
| Dose-proportionality | AUC0-∞ | 0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h |
| Dose-proportionality | Cmax | 0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h |
| Dose-proportionality | Tmax | 0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h |
| Dose-proportionality | t½β | 0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Adverse Event/Serious Adverse Event monitoring Physical Examination, Vital Sign, 12-lead ECG, Lab Tests | 0(predose), 4, 8, 12, 24, 36, 48h and follow-up visit(22d±1d) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| KS Bae, Ph.D | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medcial Center | Songpa-gu | Seoul | 138-736 | South Korea |
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| ID | Term |
|---|---|
| D060050 | Angina, Stable |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| D014652 |
| Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |