The PK and PD Interaction Between YH4808, Amoxicillin and Clarithromycin in Healthy Subjects

Study Overview
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Brief Summary
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The objective of this study is not only to explore pharmacokinetic interaction after single oral administration but also pharmacodynamics interaction after multiple oral administration of YH4808, amoxicillin and clarithromycin each separately versus coadministration of YH4808, amoxicillin and clarithromycin in healthy volunteers

Official Title
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The Exploration for Pharmacodynamics and Pharmacokinetic Interaction Between YH4808, Amoxicillin and Clarithromycin in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: YH4808
* Drug: Nexium
* Drug: Amoxicillin
* Drug: clarithromycin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy male age 20 to 55 over 55kg with Ideal body weight(BMI:18.5 25) Subject who has no congenital, chronic disease and disease symptoms in medical examination result Subject who is judged to be eligible by principal investigator or sub-investigator according to various reasons including their abnormal test results(clinical laboratory test, 12-lead GCG etc) Exclusion Criteria: Subject who is hypersensitive to components contained in YH4808 or this drug Subject who has history or presence of clinically significant diseases in liver, kidney, gastrointestinal tract, nervous system, respiratory system, endocrine system, blood tumor, cardiovascular, urinary system, and mental disorder Subject who has history of surgical operation or diseases related to gastrointestinal symptom (e.g. Crohn's disease, ulcer etc except appendectomy or simple for hernia) Other exclusions apply

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

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: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: YH4808, amoxicillin, clarithromycin<br>single administration of YH4808 or amoxicillin or clarithromycin or YH4808 + amoxicillin + clarithromycin | Drug: YH4808<br> <br> * Other names: experimental drug;Drug: Amoxicillin<br> <br> * Other names: experimental drug;Drug: clarithromycin<br> <br> * Other names: experimental drug;|
| Experimental: YH4808, amoxicillin and clarithromycin<br>7 days repeat administration of YH4808, amoxicillin and clarithromycin for H.pylori eradication | Drug: YH4808<br> <br> * Other names: experimental drug;Drug: Amoxicillin<br> <br> * Other names: experimental drug;Drug: clarithromycin<br> <br> * Other names: experimental drug;|
| Experimental: YH4808 and amoxicillin<br>7 days repeat administration of YH4808 and amoxicillin for H.pylori eradication | Drug: YH4808<br> <br> * Other names: experimental drug;Drug: Amoxicillin<br> <br> * Other names: experimental drug;|
| Active Comparator: nexium, amoxicillin and clarithromycin<br>BID, 7 days repeat administration of nexium, amoxicillin and clarithromycin for H.pylori eradication | Drug: Nexium<br> <br> * Other names: active comparator;Drug: Amoxicillin<br> <br> * Other names: experimental drug;Drug: clarithromycin<br> <br> * Other names: experimental drug;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax, AUClast of YH4808, M3, amoxicillin, clarithromycin, 14-hydroxyclarithromycin |  | pre dose, 16 times after dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax, AUClast of M8, AUCinf, t1/2, Tmax of YH4808, M3, M8, amoxicillin, clarithromycin, 14-hydroxyclarithromycin |  | pre dose, 16 times after dosing | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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safety/tolerability and pharmacokinetics/pharmacodynamics