Food-Effect on PK and PD of Single Oral Dose of Tegoprazan in Healthy Male Subjects

Study Overview
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Brief Summary
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This study aims to evaluate the food-effect of tegoprazan 50mg on the pharmacokinetics and pharmacodynamics in healthy H. pylori negative male volunteers

Detailed Description
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Primary Outcome Measure: AUClast and Cmax of tegaprazan Gastric pH

Official Title
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A Randomized, Open-label, Single-dose Phase 1 Clinical Trial to Compare the Effect of Timing of Food on the Pharmacokinetics and Pharmacodynamics of K-CAB (Tegoprazan) in Healthy Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Tegoprazan 50mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adult males aged ≥ 19 years and ≤ 50 years Body weight of ≥ 55.0 kg and ≤ 90.0 kg, with body mass index (BMI) of ≥ 18.0 kg/m2 and ≤ 27.0 kg/m2 at the time of screening Helicobacter pylori negative Exclusion Criteria: Presence or history of clinically significant diseases Presence or history of gastrointestinal disorder (gastric ulcer, GERD, Crohn's disease, etc.) Hypersensitivity to drugs containing study drug or proton pump inhibitor and other drugs (aspirin, antibiotics, etc.) or history of clinically significant hypersensitivity Serologic test positive Abnormal obstacle to insertion and maintenance of pH meter catheter History of drug abuse Excessive caffeine intake or persistent alcohol intake Not use of a medically acceptable method of contraception

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

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: Tegoprazan 50mg under fasting condition<br>Treatment A: single oral administration of Tegoprazan 50mg tablet under fasting condition once a day | Drug: Tegoprazan 50mg<br>* K-CAB<br>* Other names: Tegoprazan 50mg tablet;|
| Experimental: Tegoprazan 50mg before the meal<br>Treatment B: single oral administration of Tegoprazan 50mg tablet before the meal once a day | Drug: Tegoprazan 50mg<br>* K-CAB<br>* Other names: Tegoprazan 50mg tablet;|
| Experimental: Tegoprazan 50mg after the meal<br>Treatment C: single oral administration of Tegoprazan 50mg tablet after the meal once a day | Drug: Tegoprazan 50mg<br>* K-CAB<br>* Other names: Tegoprazan 50mg tablet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUClast of tegaprazan | Area under the plasma concentration versus time curve of tegoprazan | Pre-dose(0 hour) and up to 48 hours in each period | 
| Cmax of tegaprazan | Peak Plasma Concentration of tegoprazan | Pre-dose(0 hour) and up to 48 hours in each period | 
| Gastric pH | Gastric pH | Pre-dose(0 hour) up to 24 hours after Investigational product administration in each period |