Evaluating Dose-proportionality of Dilatrend Suspended-Release Capsule

Study Overview
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Brief Summary
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This study is designed to evaluate dose-proportionality of Dilatrend SR 8mg, 16mg, 32mg, 64mg, 128mg in healthy male volunteers.

Official Title
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A Randomized, Open-label, Single Dose, Dose-rising 10-sequence, 3-period Balanced Incomplete Blocked Clinical Trial to Evaluate Dose-proportionality of Dilatrend SR in Healthy Male Volunteers

Conditions
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Chronic Stable Angina

Intervention / Treatment
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* Drug: Dilatrend SR capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age range 20 to 54 years, Body mass index of ≥19 and ≤26 healthy male volunteers Able to participate in all procedure SBP 90-140 mmHg, DBP 60-90 mmHg, Pulse rate 55-95 times/min Have given written informed consent Exclusion Criteria: Have history of significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, musculoskeletal neurologic disease Have history of gastrointestinal disease(Crohn's disease, gastrointestinal ulcer) or surgery(except for Appendectomy, Hernia) Have allergy or hypersensitivity to carvedilol or any component of the formulation(aspirin, antibiotics) Have history of drug abuse. A positive test for any drug(amphetamine, barbiturates, cocaine, opiates, benzodiazepines, THC, methadone, ect.) included in the urine drug screen. Have herbal drug within 30days prior to the first IP administration, have ETC within 14days prior to the first IP administration, have OTC 7days prior to the first IP administration. Have diet which may influence on the absorption, distribution, metabolism or excretion of drug(s), (Drinking over 1L of grapefruit juice within 7days prior to the first IP administration) Have received an investigational drug within 60 days prior to the first IP administration Have donated whole blood within 60 days prior or donation plasma within 30 days prior to the first IP administration Have any metabolic enzyme including or inhibiting drugs like barbiturates within 30 days prior to the first IP administration. A heavy caffeine/alcohol consumer or a heavy smoker(caffeine > 5 units/days. alcohol >21 units/week (1 unit=pure alcohol 10mL), Cigarette > 10 Cigarettes/day) or alcohol abuse. Positive for Hepatitis B, Hepatitis C, HIV or syphilis

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 54 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dilatrend SR capsule 8mg<br> | Drug: Dilatrend SR capsule<br>* single oral administration in period 1 or 2, 3 for each sequential group.<br>|
| Experimental: Dilatrend SR capsule 16mg<br> | Drug: Dilatrend SR capsule<br>* single oral administration in period 1 or 2, 3 for each sequential group.<br>|
| Experimental: Dilatrend SR capsule 32mg<br> | Drug: Dilatrend SR capsule<br>* single oral administration in period 1 or 2, 3 for each sequential group.<br>|
| Experimental: Dilatrend SR capsule 64mg<br> | Drug: Dilatrend SR capsule<br>* single oral administration in period 1 or 2, 3 for each sequential group.<br>|
| Experimental: Dilatrend SR capsule 128mg<br> | Drug: Dilatrend SR capsule<br>* single oral administration in period 1 or 2, 3 for each sequential group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) |