[KJ-INT-002] BE Study

Study Overview
=================
Brief Summary
-----------------
Assess the Safety and the Pharmacokinetic Characteristics of INT-2150 after Oral Administration to Healthy Adult Male Subjects

Official Title
-----------------
A Randomized, Open-label, Crossover Clinical Study to Assess the Safety and the Pharmacokinetic Characteristics of INT-2150 After Oral Administration to Healthy Adult Male Subjects

Conditions
-----------------
Gastritis

Intervention / Treatment
-----------------
* Drug: INT-2150
* Drug: Irsogladine maleate 2 mg+Nizatidine 150 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male aged between 19 and 45 years of age inclusive, at the time of signing the informed consent. Body weight >= 50 kilogram (kg) and body mass index within the range 18 - 29.0kg/m^2 (inclusive). Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form Exclusion Criteria: Patients with a history of abnormal digestive organ, kidney, respiratory, neuroendocrine, cardiovascular, hemato-oncology, urinary, muscloskeletal, immune, the nose and ears, psychiatry, stomach system. History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator contraindicates their participation. Systolic blood pressure ≥ 150 or ≤ 100 mmHg, Diasolic blood pressure ≥ 95 or ≤ 55 mmHg. Gastrointestinal disease or with gastrointestinal surgical history which can affect the absorption of the investigational product. Alanine aminotransferase, alkaline phosphatase <=2x upper limit of normal (ULN) total bilirubin > 2.0mg/dl and eGRF <60mL/min/1.73m2 History of regular alcohol consumption within 6 months of the study defined as: An average weekly intake of >21 units for males. One unit is equivalent to 10 gram of alcohol. The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 90 days of the biological effect of the investigational product (whichever is longer).

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 45 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 |
| --- | --- |
| Other: INT2150-A<br> | Drug: INT-2150<br>* Period: INT-2150 Period: Irsogladine maleate 2 mg+Nizatidine 150 mg<br>Drug: Irsogladine maleate 2 mg+Nizatidine 150 mg<br>* Period: Irsogladine maleate 2 mg+Nizatidine 150 mg Period: INT-2150<br>|
| Other: INT2150-B<br> | Drug: INT-2150<br>* Period: INT-2150 Period: Irsogladine maleate 2 mg+Nizatidine 150 mg<br>Drug: Irsogladine maleate 2 mg+Nizatidine 150 mg<br>* Period: Irsogladine maleate 2 mg+Nizatidine 150 mg Period: INT-2150<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCt | Pharmacokinetic Characteristics | One day | 
| Cmax | Pharmacokinetic Characteristics | One day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC∞ | Pharmacokinetic Characteristics | One day | 
| tmax | Pharmacokinetic Characteristics | One day | 
| t1/2 | Pharmacokinetic Characteristics | One day |