Study to Evaluate the Safety and Pharmacodynamic/Pharmacokinetic Characteristics of HIP2101 in Healthy Volunteers

Study Overview
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Brief Summary
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A Phase 1 Study to Evaluate the Safety and Pharmacodynamic/Pharmacokinetic Characteristics of HIP2101 in Healthy Volunteers

Detailed Description
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A Randomized, Open-label, Multiple-dose, Crossover Phase 1 Clinical Trial to Evaluate the Safety and Pharmacodynamic/Pharmacokinetic Characteristics after Oral Administration of HIP2101 in Healthy Adult Volunteers

Official Title
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A Randomized, Open-label, Multiple-Dose, Crossover Phase 1 Clinical Trial to Evaluate the Safety and Pharmacodynamic/Pharmacokinetic Characteristics After Oral Administration of HIP2101 in Healthy Adult Volunteers

Conditions
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Healthy Adult Volunteer

Intervention / Treatment
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* Drug: HIP2101
* Drug: RLD2101


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers in the age between 19 and 50 years old. Body mass index (BMI) in the range of 18 to 30 kg/m2 and weight 50.0kg to 90.0kg. 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 (Crohn's disease or Acute/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 investigational product or the same component or other drugs. Aspartate aminotransferase and alanine aminotransferase exceed 2 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 6 months before the first administration or who cannot abstain from consent to post-study visit. 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 A<br>Period I : RLD2104 Period II : HIP2104 | Drug: HIP2101<br>* Test drug<br>Drug: RLD2101<br>* Reference drug<br>|
| Experimental: Sequence B<br>Period I : HIP2104 Period II : RLD2104 | Drug: HIP2101<br>* Test drug<br>Drug: RLD2101<br>* Reference drug<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration time with integrated gastric pH>4 / 24hr |  | 0-24hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median 24 hr gastric pH |  | 0-24hours | 
| Percent decrease from baseline in integrated gastric acidity for 24-hour interval after dose |  | 0-24hours |