Safety, Pharmacokinetics and Pharmacodynamics of the Two Esomeprazole Formulations

Study Overview
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Brief Summary
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This study is a Randomized, Open-label, Multiple Dose, Crossover Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP1601 (40 mg or 20 mg) to HGP1705 (40 mg or 20 mg) After Multiple Administrations in Healthy Male Volunteers

Detailed Description
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This study is a 2-part study, where in Part A, the 40 mg dose will be performed followed by the 20 mg dose in Part B.

Official Title
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A Randomized, Open-label, Multiple Dose, Crossover Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP1601 (40 mg or 20 mg) to HGP1705 (40 mg or 20 mg) After Multiple Administrations in Healthy Male Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: HIP1601
* Drug: HGP1705


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 19 50 years in healthy male volunteers BMI is more than 18 kg/m^2 , no more than 27.0 kg/m^2 Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing Exclusion Criteria: Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system Subjects who judged ineligible by the investigator

Ages Eligible for Study
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Minimum Age: 19 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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence Group 1<br>Period 1: Reference Drug(HGP1705) Period 2: Test Drug(HIP1601) | Drug: HIP1601<br>* Test Drug<br>* Other names: Esomeprazole (40 mg or 20 mg);Drug: HGP1705<br>* Reference Drug<br>* Other names: Nexium(esomeprazole 40 mg or 20 mg);|
| Experimental: Sequence Group 2<br>Period 1: Test Drug(HIP1601) Period 2: Reference Drug(HGP1705) | Drug: HIP1601<br>* Test Drug<br>* Other names: Esomeprazole (40 mg or 20 mg);Drug: HGP1705<br>* Reference Drug<br>* Other names: Nexium(esomeprazole 40 mg or 20 mg);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUClast of esomeprazole | pharmacokinetic evaluation | 1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 4 Day 0 hour, 5 Day 0 hour, 6 Day 0 hour, 7 Day 0 hour, 8 Day 0 hour | 
| After 7days of repeated administration, Total gastric acidity decrease rate versus baseline for 24 hours | pharmacodynamic evaluation | 7Day 24h(Full time) pH monitoring | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf of esomeprazole | pharmacokinetic evaluation | 1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 4 Day 0 hour, 5 Day 0 hour, 6 Day 0 hour, 7 Day 0 hour, 8 Day 0 hour | 
| Cmax of esomeprazole | pharmacokinetic evaluation | 1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 4 Day 0 hour, 5 Day 0 hour, 6 Day 0 hour, 7 Day 0 hour, 8 Day 0 hour | 
| Tmax of esomeprazole | pharmacokinetic evaluation | 1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 4 Day 0 hour, 5 Day 0 hour, 6 Day 0 hour, 7 Day 0 hour, 8 Day 0 hour | 
| Terminal Half-life of esomeprazole | pharmacokinetic evaluation | 1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 4 Day 0 hour, 5 Day 0 hour, 6 Day 0 hour, 7 Day 0 hour, 8 Day 0 hour | 
| CL/F of esomeprazole | pharmacokinetic evaluation | 1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 4 Day 0 hour, 5 Day 0 hour, 6 Day 0 hour, 7 Day 0 hour, 8 Day 0 hour | 
| Vd/F of esomeprazole | pharmacokinetic evaluation | 1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 4 Day 0 hour, 5 Day 0 hour, 6 Day 0 hour, 7 Day 0 hour, 8 Day 0 hour | 
| Ctrough | pharmacokinetic evaluation | 1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 51 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 2 Day 0 hour | 
| Ctrough,ss | pharmacokinetic evaluation | 1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 4 Day 0 hour, 5 Day 0 hour, 6 Day 0 hour, 7 Day 0 hour, 8 Day 0 hour | 
| PTF | pharmacokinetic evaluation | 1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 4 Day 0 hour, 5 Day 0 hour, 6 Day 0 hour, 7 Day 0 hour, 8 Day 0 hour | 
| RActrough | pharmacokinetic evaluation | 1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 4 Day 0 hour, 5 Day 0 hour, 6 Day 0 hour, 7 Day 0 hour, 8 Day 0 hour | 
| After the first administration of esomeprazole, The rate of decrease of integrated gastric acidity compared to baseline for 24 hours | pharmacodynamic evaluation | 1Day 24h pH monitoring | 
| After the first dose and 7 days of repeated dosing, Percentage of time to maintain gastric pH 4.0 or higher for 24 hours | pharmacodynamic evaluation | 1Day(Full time) pH monitoring, 7Day 24h(Full time) pH monitoring | 
| After the first administration and 7 days of repeated administration, The median pH measured for 24 hours | pharmacodynamic evaluation | 1Day(Full time) pH monitoring, 7Day 24h(Full time) pH monitoring | 
| After first administration and 7 days of repeated administration, Total gastric acidity reduction rate versus baseline between 12hours and 24 hours | pharmacodynamic evaluation | 1Day 12h, 2Day 0h, 7Day 12h, 8Day 0h | 
| After the first dose and 7 days of repeated dosing, Percentage of time to maintain gastric pH 4.0 or higher between 12hours and 24 hours | pharmacodynamic evaluation | 1Day 12h, 2Day 0h, 7Day 12h, 8Day 0h | 
| After the first dose and 7 days of repeated dosing, The median pH measured between 12hours and 24 hours | pharmacodynamic evaluation | 1Day (12 24h) pH monitoring, 7Day (12 24h) pH monitoring |