Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP2105 to RLD2104 in Healthy Volunteers

Study Overview
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Brief Summary
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A Phase 1 Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP2105 to RLD2104 in Healthy Volunteers

Detailed Description
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A Randomized, Open-label, Multiple dose, Crossover Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP2105 to RLD2104 in Healthy Volunteers

Official Title
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A Randomized, Open-label, Multiple Dose, Crossover Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP2105 to RLD2104 in Healthy Volunteers

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: HIP2105
* Drug: RLD2104


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 19 to 28 kg/m2 and weight 55.0kg 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 (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 investigational product or the same component or other drugs (aspirin, antibiotics, etc.). 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: Test drug(HIP2105) or Reference drug(RLD2104) Sequence 1<br>Period 1: RLD2104 Period 2: HIP2105 | Drug: HIP2105<br>* Test drug<br>Drug: RLD2104<br>* Reference drug<br>|
| Experimental: Test drug(HIP2105) or Reference drug(RLD2104) Sequence 2<br>Period 1: HIP2105 Period 2: RLD2104 | Drug: HIP2105<br>* Test drug<br>Drug: RLD2104<br>* Reference drug<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCtau |  | 0-24hours | 
| changed rate from baseline in 24h integrated gastric pH |  | 0-24hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax |  | 0-24hours | 
| Tmax |  | 0-24hours | 
| t1/2 |  | 0-24hours | 
| CL/F |  | 0-24hours | 
| Vd/F |  | 0-24hours | 
| AUClast |  | 0-24hours | 
| Cmin,ss |  | 0-24hours | 
| Cmax,ss |  | 0-24hours | 
| t1/2,ss |  | 0-24hours | 
| CLss/F |  | 0-24hours | 
| Vd,ss/F |  | 0-24hours | 
| changed rate from baseline in 24h integrated gastric pH |  | 0-24hours | 
| Duration time with integrated gastric pH>4 / 24hr |  | 0-24hours | 
| Median 24 hr gastric pH |  | 0-24hours |