Clinical Trial to Evaluate Food-Effects on Pharmacokinetics and Pharmacodynamics of Oral Single Dose of JP-1366 Tablet in Healthy Volunteers

Study Overview
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Brief Summary
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To Evaluate Food-Effects on Pharmacokinetics and Pharmacodynamics of Oral single dose of JP-1366 tablet in Healthy volunteers

Official Title
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A Randomized, Open-label, Crossover Phase 1 Clinical Trial to Evaluate Food-Effects on Pharmacokinetics and Pharmacodynamics of Oral Single Dose of JP-1366 Tablet in Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: JP-1366 20mg tablet
* Drug: JP-1366 20mg tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A healthy adult aged between 19 and 45 years old BMI between 18.0kg/m2 and 27.0kg/m2 at the time of screening Exclusion Criteria: The subject who has clinically significant disease with liver, endocrine system, immune system, nervous system, kidney, cardiovascular disease, mental disorder, the blood of tumor disease, respiratory system or with history of the disease. The subject who has a history of gastrointestinal disorders(e.g., gastroesophageal reflux disease, gastrospasm, gastritis, gastrointestinal ulcers, Crohn's disease, etc.) or history of gastrointestinal surgery The subject who has an allergic disease(excluding mild allergic rhinitis that does not require administration) or has a history of clinically significant hypersensitivity or adverse reactions to clinical trial drugs or drugs containing the same or other drugs (aspirin, NSAIDs, antibiotics, etc.). The subject who has other clinically significant diseases or history The subject who has a history of drug abuse The subject who cannot withstand the insertion and maintenance of pH catheters

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 45 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>T → Washout period(7-14days) → R | Drug: JP-1366 20mg tablet<br>* T : JP-1366 20mg tablet after the meal<br>Drug: JP-1366 20mg tablet<br>* R : JP-1366 20mg tablet under fasting condition<br>|
| Experimental: Sequence 2<br>R → Washout period(7-14days) → T | Drug: JP-1366 20mg tablet<br>* T : JP-1366 20mg tablet after the meal<br>Drug: JP-1366 20mg tablet<br>* R : JP-1366 20mg tablet under fasting condition<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of JP-1366 |  | Pre-dose(0 hour) and up to 34 hours in each period | 
| AUClast of JP-1366 |  | Pre-dose(0 hour) and up to 34 hours in each period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric pH |  | Pre-dose(0 hour) up to 24 hours after Investigational product administration |