Food-effect on PK and PD of Single Oral Dose of HIP1601 in Healthy Subjects

Study Overview
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Brief Summary
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Primary objective - To evaluate food effect on the pharmacokinetics and the pharmacodynamics (PD) of a single oral dose of HIP1601 in healthy subjects under fed or fasting condition. Secondary objectives - To evaluate the safety of single oral dose of HIP1601 in healthy subjects under fed or fasting condition.

Official Title
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A Randomized, Open-label, Single Dose, Crossover Study to Investigate the Effect of Food on the Pharmacokinetics and Pharmacodynamics of HIP1601 40 mg in Healthy Volunteers

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: HIP1601 40mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male/Female healthy volunteers in the age between 19 and 50 years old. Body mass index (BMI) in the range of 19 to 28 kg/m2 and weight 55.0kg to 90.0kg. Helicobacter pylori (H. Pylori) negative. After fully hearing and understanding the details of this clinical trial, Subjects who have willingness to sign of informed consent before the screening. Subject who are eligible from physical examination, clinical laboratory test by investigators judgment. Exclusion Criteria: Gastrointestinal disorders (gastrointestinal ulcers, gastritis, stomach cramps, gastro-esophageal reflux disease, Crohn's disease or chronic pancreatitis) or gastrointestinal surgery (except for simple cecal or hernia surgery) which may affect the safety and pharmacokinetic evaluation of test drug. Subjects who have a history of hypersensitivity or clinically significant hypersensitivity to esomeprazole or the same component or other drugs (aspirin, antibiotics, etc.). Blood serum aspartate aminotransferase and alanine aminotransferase exceed 1.5 times the upper limit of normal range from screening laboratory results before randomization. Subject who continues to drink (21 units / week, 1 unit = 10 g of pure alcohol) within a month before the screening visit or who cannot abstain during the hospital stay. Heavy smoker (>10 cigarettes/day).

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 50 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>Period 1: Fasted state + HIP1601 Period 2: Fed state + HIP1601 | Drug: HIP1601 40mg<br>* Single dosing of HIP1601 40mg, PO<br>* Other names: HIP1601;|
| Experimental: Sequence 2<br>Period 1: Fed state + HIP1601 Period 2: Fasted state + HIP1601 | Drug: HIP1601 40mg<br>* Single dosing of HIP1601 40mg, PO<br>* Other names: HIP1601;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | Maximum observed concentration after dose | Blood sampling during 24 hours after administration | 
| Area Under the plasma concentration versus time Curve(AUC)last | Area under the plasma concentration versus time curve from dosing to the last quantifiable concentration | Blood sampling during 24 hours after administration | 
| Integrated gastric acidity for 24-hour | Percent decrease from baseline in integrated gastric acidity for 24-hour interval after dose | Blood sampling during 24 hours after administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tmax | Time of Cmax over the time span specified | Blood sampling during 24 hours after administration | 
| AUCinf | Area under the plasma concentration versus time curve from the time of dosing to time extrapolated to infinitely | Blood sampling during 24 hours after administration | 
| t1/2 | Terminal half-life | Blood sampling during 24 hours after administration | 
| Clearance/F | Apparent total body clearance after extravascular administration, calculated as Dose/AUCinf | Blood sampling during 24 hours after administration | 
| Vd/F | Apparent volume of distribution after extravascular administration, calculated as Dose/(λzㆍAUCinf) | Blood sampling during 24 hours after administration | 
| Duration of time intra-gastric pH 4.0 or higher | Percent of time with intra-gastric pH greater than 4.0 for 24-hour interval after dose | Blood sampling during 24 hours after administration | 
| Median pH | Median intra-gastric pH for 24-hour interval after dose | Blood sampling during 24 hours after administration |