Evaluate the PK of Multiple Oral Doses of Tegoprazan, Metronidazole, Tetracycline and Bismuth in Healthy Volunteers

Study Overview
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Brief Summary
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This study aims to evaluate the pharmacokinetic interaction between tegoprazan and combination of metronidazole, tetracycline and bismuth in healthy adult volunteers.

Detailed Description
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A open-label, randomized, multiple dose, two arm, two period, crossover study

Official Title
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An Open-Label, Randomized, Crossover Study to Evaluate the Pharmacokinetic Interaction After Multiple Oral Doses of Tegoprazan, Metronidazole, Tetracycline and Bismuth in Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: Tegoprazan
* Drug: Metronidazole
* Drug: Tetracycline
* Drug: Bismuth


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adult aged ≥ 19 and < 55 year-old on the day of obtaining the informed consent. Body mass index (BMI) ≥ 17.5 kg/m2 and < 28.0 kg/m2 with a body weight ≥ 55 kg at screening. H. pylori negative. Exclusion Criteria: Medical History History or evidence of clinically significant disease History of gastrointestinal disease (e.g., esophageal disease such as esophageal achalasia or stenosis, and Crohn's disease) or surgery that may affect the absorption of a drug. History or presence of hypersensitivity to IMPs, components of IMPs, benzimidazoles, imidazole derivatives or tetracycline antibiotics Laboratory tests(in blood) 1) Total bilirubin, AST (GOT), ALT (GPT) > 1.5 X upper limit of normal (ULN) at screening History of drug/alcohol abuse Participated in other study and received investigational product within 3 months prior to the first study dose. taken a medication known to substantially induce or inhibit a drug metabolizing enzyme 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 |
| --- | --- |
| Active Comparator: Tegoprazan 50 mg<br>Oral administration of Tegoprazan 50 mg twice daily for 7 days | Drug: Tegoprazan<br>* Tegoprazan 50 mg tablet<br>* Other names: K-CAB;|
| Active Comparator: Tegoprazan 50 mg+MTN 500 mg+TCL 500 mg+BIS 300 mg<br>Oral administration of Tegoprazan 50 mg twice daily, Metronidazole 500 mg three times daily, and Tetracycline hydrochloride 500 mg & Tripotassium bismuth dicitrate 300 mg four times daily for 7 days | Drug: Tegoprazan<br>* Tegoprazan 50 mg tablet<br>* Other names: K-CAB;Drug: Metronidazole<br>* Metronidazole 250 mg tablet<br>* Other names: Flasinyl;Drug: Tetracycline<br>* Tetracycline hydrochloride 250 mg capsule<br>* Other names: Teracyclin;Drug: Bismuth<br>* Tripotassium bismuth dicitrate 300 mg tablet<br>* Other names: Denol;|
| Active Comparator: MTN 500 mg+TCL 500 mg+BIS 300 mg<br>Oral administration of Metronidazole 500 mg twice daily, Tetracycline hydrochloride 500 mg & Tripotassium bismuth dicitrate 300 mg four times daily for 7 days | Drug: Metronidazole<br>* Metronidazole 250 mg tablet<br>* Other names: Flasinyl;Drug: Tetracycline<br>* Tetracycline hydrochloride 250 mg capsule<br>* Other names: Teracyclin;Drug: Bismuth<br>* Tripotassium bismuth dicitrate 300 mg tablet<br>* Other names: Denol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0-12 of tegaprazan and metabolite M1 | Area under the plasma concentration versus time curve of tegoprazan | pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in period1 ,2. | 
| Cmax of tegaprazan and metabolite M1 | Peak Plasma Concentration of tegoprazan and metabolite M1 | pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in period1 ,2. | 
| AUC0-6 of metronidazole, tetracycline and bismuth | Area under the plasma concentration versus time curve of metronidazole, tetracycline and bismuth | pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in period1 ,2. | 
| Cmax of metronidazole, tetracycline and bismuth | Peak Plasma Concentration of metronidazole, tetracycline and bismuth | pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in period1 ,2. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug-Drug interaction, pharmacokinetic