Pharmacokinetic Interaction Between Tegoprazan and NSAIDs After Multiple Oral Dosing in Healthy Male Volunteers

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate the pharmacokinetic (PK) interaction between tegoprazan and non-steroidal anti-inflammatory drugs (NSAIDs) after given each alone and in their combination in healthy male adults.

Detailed Description
-----------------
A randomized, open-label, multiple-dose, 6-sequence-arm, 3-period cross-over study

Official Title
-----------------
An Open-label, Randomized, Crossover Study to Evaluate the Pharmacokinetic Interaction Between Tegoprazan and Non-steroidal Anti-inflammatory Drugs (NSAIDs) After Multiple Oral Dosing in Healthy Male Volunteers

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Tegoprazan
* Drug: Naproxen
* Drug: Aceclofenac
* Drug: Celecoxib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adult aged ≥ 19 and < 55 year-old at screening Body mass index (BMI) ≥ 19.0 kg/m2 and < 27.0 kg/m2 with a body weight ≥ 55 kg at screening. Exclusion Criteria: History or evidence of clinically significant disease History of GI disease or surgery that may affect the absorption of a drug Laboratory test result which falls into the following values( ALT or AST > 2 × upper limit of normal (ULN)) History of regular alcohol consumption exceeding 210 g/week within 6 months Daily use of ≥ 20 cigarettes within 6 months Has taken any investigational agent within 6 months prior to the first dose of IMP Subjects who are considered ineligible to participate in this study at the discretion of the investigator.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

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>Multiple doses of tegoprazan alone once daily (QD) for 7 days | Drug: Tegoprazan<br>* Tegoprazan 50 mg tablet<br>* Other names: K-CAB;|
| Active Comparator: NSAIDs<br>Multiple doses of NSAIDs alone twice daily (BID) for 7 days | Drug: Naproxen<br>* Naproxen 500 mg tablet<br>* Other names: Naxen-F;Drug: Aceclofenac<br>* Aceclofenac 100 mg tablet<br>* Other names: Airtal;Drug: Celecoxib<br>* Celecoxib 200 mg capsule<br>* Other names: Celebrex 200 mg;|
| Active Comparator: Tegoprazan 50 mg + NSAIDs<br>Multiple doses of tegoprazan QD in combination with NSAIDs BID for 7 days | Drug: Tegoprazan<br>* Tegoprazan 50 mg tablet<br>* Other names: K-CAB;Drug: Naproxen<br>* Naproxen 500 mg tablet<br>* Other names: Naxen-F;Drug: Aceclofenac<br>* Aceclofenac 100 mg tablet<br>* Other names: Airtal;Drug: Celecoxib<br>* Celecoxib 200 mg capsule<br>* Other names: Celebrex 200 mg;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCτ of tegoprazan and NSAIDs | Area under the plasma concentration-time curve during a steady-state dosing interval (τ) of tegoprazan and NSAIDs | pre-dose (0 hour) on Day1, Day5, Day6 and pre-dose up to 24 hours post-dose on Day7 | 
| Css,max of tegoprazan and NSAIDs | Maximum Plasma Concentration at Steady State of tegoprazan and NSAIDs | pre-dose (0 hour) on Day1, Day5, Day6 and pre-dose up to 24 hours post-dose on Day7 | 

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