YH4808 Postprandial PK/PD Study in Healthy Subjects

Study Overview
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Brief Summary
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A clinical Study to evaluate the safety and pharmacokinetics/pharmacodynamics(PK/PD) of YH4808 after repeated Oral administration and Postprandial state in healthy volunteers

Official Title
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A Randomized,Open Label,Active-controlled, Multiple Dosing and Crossover Clinical Trial to Evaluate the Safety and Pharmacokinetics/Pharmacodynamics of YH4808 After Postprandial Oral Administration in Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: YH4808
* Drug: YH4808
* Drug: YH4808
* Drug: YH4808


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and female aged 20 to 55 with a body mass index(BMI) between 18.5 and 25 kg/m2 Subject who has no congenital, chronic diseases and disease symptoms in medical examination result Subject who shows negative reaction of UBT(Urea Breath Test) 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, chest X-ray test, 12-lead ECG etc) 4 weeks before the first IP adminitration Medically acceptable contraception(including individuals who are medically unable to become pregnant) used during the clinical trial Volunteers who has signed a written informed consent voluntarily, prior to any procedure, using a form that is approved by the local Institutional Review Board after detail explanation of the purpose, contents, and characteristic of the drug 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 symtem (e.g. crohn's disaese, ulcer etc except appendectomy or simple for herina) 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: 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<br>* Group1 adminitration of YH4808 dose1, bid for 2weeks wash-out period for 3weeks between period1 and period2 adminitration of YH4808 dose2, qd for 2weeks<br>Drug: YH4808<br>* Group2 adminitration of YH4808 dose2, qd for 2weeks wash-out period for 3weeks between period1 and period2 adminitration of YH4808 dose1, bid for 2weeks<br>Drug: YH4808<br>* Group3 adminitration of YH4808 dose2, bid for 2weeks wash-out period for 3weeks between period1 and period2 adminitration of Nexium tab 40mg, bid for 2weeks<br>* Other names: YH4808, Nexium;Drug: YH4808<br>* Group 4 adminitration of Nexium tab 40mg, bid for 2weeks wash-out period for 3weeks between period1 and period2 adminitration of YH4808 dose2, bid for 2weeks<br>* Other names: Nexium;|
| Experimental: Sequence 2<br> | Drug: YH4808<br>* Group1 adminitration of YH4808 dose1, bid for 2weeks wash-out period for 3weeks between period1 and period2 adminitration of YH4808 dose2, qd for 2weeks<br>Drug: YH4808<br>* Group2 adminitration of YH4808 dose2, qd for 2weeks wash-out period for 3weeks between period1 and period2 adminitration of YH4808 dose1, bid for 2weeks<br>Drug: YH4808<br>* Group3 adminitration of YH4808 dose2, bid for 2weeks wash-out period for 3weeks between period1 and period2 adminitration of Nexium tab 40mg, bid for 2weeks<br>* Other names: YH4808, Nexium;Drug: YH4808<br>* Group 4 adminitration of Nexium tab 40mg, bid for 2weeks wash-out period for 3weeks between period1 and period2 adminitration of YH4808 dose2, bid for 2weeks<br>* Other names: Nexium;|
| Active Comparator: Sequence 3<br> | Drug: YH4808<br>* Group1 adminitration of YH4808 dose1, bid for 2weeks wash-out period for 3weeks between period1 and period2 adminitration of YH4808 dose2, qd for 2weeks<br>Drug: YH4808<br>* Group2 adminitration of YH4808 dose2, qd for 2weeks wash-out period for 3weeks between period1 and period2 adminitration of YH4808 dose1, bid for 2weeks<br>Drug: YH4808<br>* Group3 adminitration of YH4808 dose2, bid for 2weeks wash-out period for 3weeks between period1 and period2 adminitration of Nexium tab 40mg, bid for 2weeks<br>* Other names: YH4808, Nexium;Drug: YH4808<br>* Group 4 adminitration of Nexium tab 40mg, bid for 2weeks wash-out period for 3weeks between period1 and period2 adminitration of YH4808 dose2, bid for 2weeks<br>* Other names: Nexium;|
| Active Comparator: Sequence 4<br> | Drug: YH4808<br>* Group1 adminitration of YH4808 dose1, bid for 2weeks wash-out period for 3weeks between period1 and period2 adminitration of YH4808 dose2, qd for 2weeks<br>Drug: YH4808<br>* Group2 adminitration of YH4808 dose2, qd for 2weeks wash-out period for 3weeks between period1 and period2 adminitration of YH4808 dose1, bid for 2weeks<br>Drug: YH4808<br>* Group3 adminitration of YH4808 dose2, bid for 2weeks wash-out period for 3weeks between period1 and period2 adminitration of Nexium tab 40mg, bid for 2weeks<br>* Other names: YH4808, Nexium;Drug: YH4808<br>* Group 4 adminitration of Nexium tab 40mg, bid for 2weeks wash-out period for 3weeks between period1 and period2 adminitration of YH4808 dose2, bid for 2weeks<br>* Other names: Nexium;|

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 |  | Blood sampling during 0   24 hrs after administration | 
| Peak plasma concentration of YH4808 |  | Blood sampling during 0 24 hrs after administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to reach peak plasma concentration of YH4808 |  | Blood sampling during 0   24 hrs after administration |