Food Effect on Pharmacokinetics of YH4808 in Healthy Male Subjects

Study Overview
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Brief Summary
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The main objective is to evaluate the food effect on the pharmacokinetic profile of YH4808 100 mg b.i.d and YH4808 300 mg after oral administration in healthy male subjects.

Official Title
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Clinical Trial to Investigate the Influence of Food on Safety/Tolerability and Pharmacokinetics of YH4808 After Oral Administration in Healthy Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: YH4808 100 mg
* Drug: YH4808 100 mg
* Drug: YH4808 300 mg
* Drug: YH4808 300 mg
* Drug: YH4808 300 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who signed written consent after receiving thorough explanation on trial purpose, content, and characteristics of investigational drug Healthy male volunteers in the age between 20 to 45 years old Weight: over 50kg, within ±20% of ideal body weight Subjects who were determined to be appropriate through screening Exclusion Criteria: Clinically significant disorder in liver, kidney, cardiovascular, respiratory system, endocrine system and CNS in the physical examination and clinical laboratory tests or a medical history of malignant tumor or psychological disease Medical history of gastrointestinal disease or acid restraining surgery, gastric/esophagus surgery (excluding appendectomy, hernia surgery) A history of hypersensitivity to drugs or clinically significant allergic disease Clinically significant abnormal values in blood chemistry(≥ 1.5 fold of normal upper limit in the levels of SGOT, SGPT) Subjects who had a history of drug abuse or who had a positive results on urine drug screening Subjects who had taken usual dose of any prescription drugs within 14 days before the treatment or who had used usual dose of OTC drugs within 7 days before the treatment(cf, be able to be enrolled in this study according to an investigatory consideration) Subjects who participated in another clinical trial within 2 months before enrolling in this study Subjects who donated whole blood within 2 months or component blood within 1 month or who are donated within 1 month before the treatment Subjects who drank Over 21 units/week of alcohol or subjects who were unable to stop drinking alcohol during the hospitalization Subjects who stopped smoking within 3 months before the treatment Subjects who had a beverage containing grapefruits within 24hrs before the hospitalization or who had a beverage containing grapefruits during the hospitalization Subjects who had a beverage containing caffeine during the hospitalization Subjects with clinically significant observations considered as unsuitable based on medical judgment by investigators

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 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: Sequence 1<br> | Drug: YH4808 100 mg<br>* Period1: YH4808 100 mg bid fasting condition for 7days Period2: YH4808 100 mg bid fed condition for 7days<br>|
| Experimental: Sequence 2<br> | Drug: YH4808 100 mg<br>* Period1: YH4808 100 mg bid fed condition for 7days Period2: YH4808 100 mg bid fasting condition for 7days<br>|
| Experimental: Sequence 3<br> | Drug: YH4808 300 mg<br>* Period1: YH4808 300 mg fasting condition Period2: YH4808 300 mg fed condition(standard meal) Period3: YH4808 300 mg fed condition(high fat meal)<br>|
| Experimental: Sequence 4<br> | Drug: YH4808 300 mg<br>* Period1: YH4808 300 mg fed condition(high fat meal) Period2: YH4808 300 mg fasting condition Period3: YH4808 300 mg fed condition(standard meal)<br>|
| Experimental: Sequence 5<br> | Drug: YH4808 300 mg<br>* Period1: YH4808 300 mg fed condition(standard meal) Period2: YH4808 300 mg fed condition(high fat meal) Period3: YH4808 300 mg fasting condition<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration versus time curve of YH4808 | non-compartmental analysis | Blood sampling during 24 or 48 hrs after administration | 
| Peak plasma concentration of YH4808 | non-compartmental analysis | Blood sampling during 24 or 48 hrs after administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to reach peak plasma concentration of YH4808 | non-compartmental analysis | Blood sampling during 24 or 48 hrs after administration |