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The purpose of this study is to compare the pharmacokinetic characteristics and safety of dilatrend SR capsule 32mg and Dilatrend tablet 25mg in healthy male subjects.
Healthy male subjects are administrated multiple-dose over the period I and II (Crossover) of dilatrend SR capsule 32mg and dilatrend tablet 25mg.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dilatrend SR capsule 32mg | Experimental |
| |
| Dilatrend IR tablet 25mg | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dilatrend SR capsule 32mg | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| In the steady state Dilatrend SR Capsule 32mg and Dilatrend tablet 25mg AUCtau | AUCtau: Area under the plasma concentration-time curve for each dosing interval (from time 0 to 48 hours sample) determined using the linear trapezoidal rule | 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48hr post-dose (on last day of each period) |
| Measure | Description | Time Frame |
|---|---|---|
| In the steady state Dilatrend SR Capsule 32mg and Dilatrend tablet 25mg AUCinf | AUCinf: Area Under the Concentration time curve with the last concentration extrapolated based on the elimination rate constant Kel | 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48hr post-dose (on last day of each period) |
| In the steady state Dilatrend SR Capsule 32mg and Dilatrend tablet 25mg Css,max |
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Inclusion Criteria:
Between 20 aged and 35aged in healthy male
Body Weight more than 50kg, and within 20% of ideal body weight(IBW).
Have not any congenital or chronic disease and medical symptoms.
Suitable results of inspections(laboratory test, ECG, etc) within 21 days before IP administration.
Agreement with written informed consent
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Young-Ran Yoon | Contact | 053-420-4950 | yry@knu.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Young-Ran Yoon | Kyungpook National University Hospital Clinical Trial Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyungpook National University Hospital Clinical Trial Center | Daegu | Eok-dong 2(i)-ga Jung-gu | 700-721 | South Korea |
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| Dilatrend IR tablet 25mg | Drug |
|
|
Css,max : Maximum drug concentration in plasma determined directly from individual concentration-time data |
| 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48hr post-dose (on last day of each period) |
| In the steady state Dilatrend SR Capsule 32mg and Dilatrend tablet 25mg Css,min | Css,min : Minimum drug concentration in plasma determined directly from individual concentration-time data | 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48hr post-dose (on last day of each period) |
| In the steady state Dilatrend SR Capsule 32mg and Dilatrend tablet 25mg Tss,max | Tss,max : Time to reach maximum drug concentration in plasma calculated from [plasma] versus time profiles | 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48hr post-dose (on last day of each period) |
| In the steady state Dilatrend SR Capsule 32mg and Dilatrend tablet 25mg t½ | t½ : Observed terminal elimination half-life | 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48hr post-dose (on last day of each period) |
| Number of participants with adverse events |
| From 1day to 37 days |
| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| D060050 | Angina, Stable |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077261 | Carvedilol |
| ID | Term |
|---|---|
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |
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