A Study to Evaluate the Drug-drug Interaction and Safety Between BR6001-1 and BR6001-2

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical trial is to evaluate the drug-drug interaction and safety between BR6001-1 and BR6001-2 in healthy adult volunteers

Official Title
-----------------
A Phase I Clinical Trial to Evaluate the Drug-drug Interaction and Safety Between BR6001-1 and BR6001-2 in Healthy Adult Volunteers

Conditions
-----------------
Gastric or Duodenal Ulcer

Intervention / Treatment
-----------------
* Drug: BR6001-1
* Drug: BR6001-2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Those who weigh 50 kg or more and have body mass index (BMI) within the range of 18.0 to 30.0kg/m² at screening visit. Those who sign written consent spontaneously to follow the study directions after listening to and understanding sufficient explanation of this clinical trial. Exclusion Criteria: Those who have a medical history of gastrointestinal diseases(Crohn's disease, ulcer, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (Except for simple appendectomy, hernia surgery) that may affect the absorption of investigational products. Those who have hypersensitivity reaction to investigational products or their additives in addition to other painkillers, anti-inflammatory drugs, antirheumatic drugs, benzimidazole. Those who have a history of clinically significant hypersensitivity reaction. Those taking anticoagulants, atazanavir, Rilpivirine and methotrexate. Those who eat an abnormal food that may affect the absorption, distribution, metabolism and excretion of investigational products or who eat food that may affect drug metabolism. Those who take any prescription drugs(including herbal medicines) that may affect characteristics of investigational product within 14 days prior to the date of first administration or who take any over-the-counter (OTC) drugs or vitamins within 10 days prior to the date of first administration (however, if it don't affect subject's safety and study's result according to the judgment of the investigator, they may participate in the study.) Those who take inducer and inhibitor of drug metabolizing enzymes such as barbiturates, etc. within 1 month prior to the first administration

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

Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BR6001-1+BR6001-2<br> | Drug: BR6001-1<br>* One tablet administered alone, Once a day<br>Drug: BR6001-2<br>* One tablet administered alone, Once a day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCτ,ss | Area under the Plasma Concentration-Time Curve During Dosing Interval (tau) at Steady State | 0 24 hours after administration | 
| Cmax,ss | Maximum Concentration of Drug in Plasma at Steady State | 0 24 hours after administration | 
| The change(%) of ARU & Thromboxane B2 (TxB2) at 24h after repeated administration (last administration date) compared to baseline (first administration date) |  | 0, 6, 24 hours after administration |