The Exploration for Pharmacodynamics and Pharmacokinetics of YH4808 New Formulation in Healthy Subjects

Study Overview
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Brief Summary
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The objective of this clinical trial is to explore pharmacodynamics and pharmacokinetics of YH4808 New Formulation in healthy volunteers.

Official Title
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A Randomized, Open-label, Multiple-dose, Partial Crossover Study to Explore the Pharmacokinetics and the Pharmacodynamics of YH4808 New Formulation in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: YH4808 NF 100
* Drug: YH4808 OF 200
* Drug: YH4808 NF 200
* Drug: YH4808 NF 400


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy adult 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 negative to Helicobacter pylori in 13C urea breath test Subject who judged to be eligible according to various test results including laboratory test(serum test, hematologic/blood chemistry examination, urine test, etc.) and 12-lead ECG test performed within 4 weeks before the first IP administration. Subject who agreed to maintain contraception and comply with medically verified contraception methods (including infertility) Exclusion Criteria: Subject who has history or presence of clinically significant disease in liver, kidney, nervous system, respiratory system, endocrine system, blood tumor, cardiovascular, reproductive, musculoskeletal system, mental disorder, ophthalmologic disease, and skin disease in investigator's judgement. Subject who has history of surgical operation or disease related to gastrointestinal symptoms (e.g. crohn's diseas, ulcer, etc. except for appendectomy or simple hernia) which could have influence on the absorption of IP. Subject who is hypersensitive to components contained in YH4808 and other drugs(aspirin, antibiotics, etc.) pregnant or lactating woman. Other exclusions apply.

Ages Eligible for Study
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Minimum Age: 19 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort1-YH4808 NF 100<br>7 days repeat administration of YH4808 New Formulation 100mg after meal | Drug: YH4808 NF 100<br>* The number of times : multiple-dose Rout : oral administration<br>|
| Experimental: Cohort1-YH4808 OF 200<br>(Partial cross over design) 7 days repeat administration of YH4808 Old Formulation 200mg after meal, 4 Weeks of wash out period, 7 days repeat administration of YH4808 New Formulation 200mg after meal | Drug: YH4808 OF 200<br>* The number of times : multiple-dose Rout : oral administration<br>Drug: YH4808 NF 200<br>* The number of times : multiple-dose Rout : oral administration<br>|
| Experimental: Cohort1-YH4808 NF 200<br>(Partial cross over design) 7 days repeat administration of YH4808 New Formulation 200mg after meal, 4 Weeks of wash out period, 7 days repeat administration of YH4808 Old Formulation 200mg after meal | Drug: YH4808 OF 200<br>* The number of times : multiple-dose Rout : oral administration<br>Drug: YH4808 NF 200<br>* The number of times : multiple-dose Rout : oral administration<br>|
| Experimental: Cohort1-YH4808 NF 400<br>7 days repeat administration of YH4808 New Formulation 400mg after meal | Drug: YH4808 NF 400<br>* The number of times : multiple-dose Rout : oral administration<br>|
| Experimental: Cohort2-YH4808 NF 100<br>7 days repeat administration of YH4808 New Formulation 100mg before meal | Drug: YH4808 NF 100<br>* The number of times : multiple-dose Rout : oral administration<br>|
| Experimental: Cohort2-YH4808 NF 200<br>(Partial cross over design) 7 days repeat administration of YH4808 New Formulation 200mg before meal, 4 Weeks of wash out period, 7 days repeat administration of YH4808 Old Formulation 200mg before meal | Drug: YH4808 OF 200<br>* The number of times : multiple-dose Rout : oral administration<br>Drug: YH4808 NF 200<br>* The number of times : multiple-dose Rout : oral administration<br>|
| Experimental: Cohort2-YH4808 OF 200<br>(Partial cross over design) 7 days repeat administration of YH4808 New Formulation 200mg before meal, 4 Weeks of wash out period, 7 days repeat administration of YH4808 Old Formulation 200mg before meal | Drug: YH4808 OF 200<br>* The number of times : multiple-dose Rout : oral administration<br>Drug: YH4808 NF 200<br>* The number of times : multiple-dose Rout : oral administration<br>|
| Experimental: Cohort2-YH4808 NF 400<br>7 days repeat administration of YH4808 New Formulation 400mg before meal | Drug: YH4808 NF 400<br>* The number of times : multiple-dose Rout : oral administration<br>|
| Experimental: Cohort3-YH4808 OF 200<br>(Partial cross over design) 7 days repeat administration of YH4808 Old Formulation 200mg before bed, 4 Weeks of wash out period, 7 days repeat administration of YH4808 Old Formulation 200mg before dinner 7 days repeat administration of YH4808 Old Formulation 200mg before dinner, 4 Weeks of wash out period, 7 days repeat administration of YH4808 Old Formulation 200mg before bed | Drug: YH4808 OF 200<br>* The number of times : multiple-dose Rout : oral administration<br>|
| Experimental: Cohort3-YH4808 OF 400<br>(Partial cross over design) 7 days repeat administration of YH4808 Old Formulation 400mg before bed, 4 Weeks of wash out period, 7 days repeat administration of YH4808 Old Formulation 400mg before dinner 7 days repeat administration of YH4808 Old Formulation 400mg before dinner, 4 Weeks of wash out period, 7 days repeat administration of YH4808 Old Formulation 400mg before bed | Drug: YH4808 OF 200<br>* The number of times : multiple-dose Rout : oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Cmax of YH4808 | Day 1(Day 35); predose, 11 times after dosing, Day 7(Day 41); predose, 13 times after dosing | Day 1(Day 35), Day 7(Day 41) | 
| The AUC0-24h of YH4808 | Day 1(Day 35); predose, 11 times after dosing, Day 7(Day 41); predose, 13 times after dosing | Day 1(Day 35), Day 7(Day 41) | 
| The AUC0-24h of M3 | Day 1(Day 35); predose, 11 times after dosing, Day 7(Day 41); predose, 13 times after dosing | Day 1(Day 35), Day 7(Day 41) | 
| The Cmax of M3 | Day 1(Day 35); predose, 11 times after dosing, Day 7(Day 41); predose, 13 times after dosing | Day 1(Day 35), Day 7(Day 41) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the arithmetic mean of 24h intragastric pH monitoring |  | Day 1(Day7) Day2(Day8) | 
| the median of 24h intragastric pH monitoring |  | Day 1(Day7) Day2(Day8) | 
| The Duration of stomach maintained over pH4 or 5 |  | Day 1(Day7) Day2(Day8) |