Study to Evaluate the Pharmacokinetic Characteristics and Safety of IN-C004 in Healthy Volunteers

Study Overview
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Brief Summary
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To evaluate the pharmacokinetic characteristics and safety of IN-C004 in healthy volunteers

Detailed Description
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An Open-label, Randomized, Single-dose, Crossover Study

Official Title
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An Open-label, Randomized, Single-dose, Crossover Study to Evaluate the Pharmacokinetic Characteristics and Safety of IN-C004 in Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: IN-C004 with water
* Drug: IN-C004 without water
* Drug: K-CAB tab. with water


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index (BMI) ≥19.0 kg/m2 and ≤27.0 kg/m2 with a body weight ≥ 45 kg at screening. Exclusion Criteria: History or evidence of clinically significant disease History of drug/alcohol abuse Participated in other studies and received investigational products within 6 months prior to the first study dose. AST(GOT) or ALT(GPT) > 2 X upper limit of normal at screening Not able to use a medically acceptable contraceptive method throughout the study.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 55 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: Group 1<br>Group 1 | Drug: IN-C004 with water<br>* One time dose of IN-C004 taken with water<br>* Other names: IN-C004;Drug: IN-C004 without water<br>* One time dose of IN-C004 taken without water<br>* Other names: IN-C004;Drug: K-CAB tab. with water<br>* One time dose of K-CAB tab. taken with water<br>* Other names: K-CAB tab.;|
| Experimental: Group 2<br>Group 2 | Drug: IN-C004 with water<br>* One time dose of IN-C004 taken with water<br>* Other names: IN-C004;Drug: IN-C004 without water<br>* One time dose of IN-C004 taken without water<br>* Other names: IN-C004;Drug: K-CAB tab. with water<br>* One time dose of K-CAB tab. taken with water<br>* Other names: K-CAB tab.;|
| Experimental: Group 3<br>Group 3 | Drug: IN-C004 with water<br>* One time dose of IN-C004 taken with water<br>* Other names: IN-C004;Drug: IN-C004 without water<br>* One time dose of IN-C004 taken without water<br>* Other names: IN-C004;Drug: K-CAB tab. with water<br>* One time dose of K-CAB tab. taken with water<br>* Other names: K-CAB tab.;|
| Experimental: Group 4<br>Group 4 | Drug: IN-C004 with water<br>* One time dose of IN-C004 taken with water<br>* Other names: IN-C004;Drug: IN-C004 without water<br>* One time dose of IN-C004 taken without water<br>* Other names: IN-C004;Drug: K-CAB tab. with water<br>* One time dose of K-CAB tab. taken with water<br>* Other names: K-CAB tab.;|
| Experimental: Group 5<br>Group 5 | Drug: IN-C004 with water<br>* One time dose of IN-C004 taken with water<br>* Other names: IN-C004;Drug: IN-C004 without water<br>* One time dose of IN-C004 taken without water<br>* Other names: IN-C004;Drug: K-CAB tab. with water<br>* One time dose of K-CAB tab. taken with water<br>* Other names: K-CAB tab.;|
| Experimental: Group 6<br>Group 6 | Drug: IN-C004 with water<br>* One time dose of IN-C004 taken with water<br>* Other names: IN-C004;Drug: IN-C004 without water<br>* One time dose of IN-C004 taken without water<br>* Other names: IN-C004;Drug: K-CAB tab. with water<br>* One time dose of K-CAB tab. taken with water<br>* Other names: K-CAB tab.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCt of tegoprazan | Area under the plasma concentration-time curve of tegoprazan | pre-dose(0 hour), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours | 
| Cmax of tegoprazan | Maximum Plasma Concentration at Steady State of tegoprazan | pre-dose(0 hour), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours | 
| AUCt of tegoprazan metabolite M1 | Area under the plasma concentration-time curve of tegoprazan metabolite M1 | pre-dose(0 hour), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hour | 
| Cmax of tegoprazan metabolite M1 | Maximum Plasma Concentration at Steady State of tegoprazan metabolite M1 | pre-dose(0 hour), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours |