A Randomized, Open-label, Single-dose, Crossover Clinical Trial to Evaluate the Food Effect on the Pharmacokinetics of Dilatrend SR 64mg Capsule After Oral Administration in Healthy Male Volunteers

Study Overview
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Brief Summary
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A randomized, open-label, single-dose, crossover clinical trial to evaluate the food effect on the pharmacokinetics of Dilatrend SR 64mg capsule after oral administration in healthy male volunteers.

Official Title
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A Randomized, Open-label, Single-dose, Crossover Clinical Trial to Evaluate the Food Effect on the Pharmacokinetics of Dilatrend SR 64mg Capsule After Oral Administration in Healthy Male Volunteers

Conditions
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Chronic Stable Angina

Intervention / Treatment
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* Drug: Dilatrend 64mg capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between 20 aged and 50 aged in healthy adults Weight more than 55kg, IBW 20% within the range Agreement with written informed consent Exclusion Criteria: Subject has hypersensitivity reaction or clinically significant history about investigational drug Clinically significant cardiovascular system, respiratory system, liver, renal, endocrine system, gastrointestinal system, central nervous system, blood tumor, mental disease, skin disease and so on Inadequate result of laboratory test AST(SGOT) or ALT(SGPT) > 1.5 x upper limit of normal range Continued to be taking caffeine (caffeine > 5 cup/day), drinking(alcohol > 210 g/day) or during clinical trials can not be drunk or severe heavy smoker (cigarette > 10 cigarettes per day) Creatinine clearance < 80ml/min Subject with known for history(such as gastrointestinal disease or operation) with affect the absorption of drug Subject takes an abnormal meal which affect the ADME of drug Previously participated in other trial within 90 days Previously make whole blood donation within 60 days or component blood donation within 30 days Subject with positive reaction for reason of laboratory test result An impossible one who participates in clinical trial by investigator's decision including for reason of laboratory test result

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 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 64mg capsule<br>* Randomized, open-label, single dose, two-period, two-way, crossover study group : Dilatrend 64mg capsule during fasting + Dilatrend 64mg capsule after high fat diet group : Dilatrend 64mg capsule after high fat diet + Dilatrend 64mg capsule during fasting | Drug: Dilatrend 64mg capsule<br>* Dilatrend 64mg capsule during fasting + Dilatrend 64mg capsule after high fat diet Dilatrend 64mg capsule after high fat diet + Dilatrend 64mg capsule during fasting<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluation of pharmacokinetics | The effect of food on PK after high fat diet and fasting Blood sampling over a 72 hour period post dose in all dosing sessions | pre-dose(0h), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluation of safety | adverse event monitoring physical examination, vital sign, ECOG, laboratory test | from screenig to post-study visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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food effect, pharmacokinetics, healthy male volunteers