To Evaluate Pharmacokinetics and Safety of Two Different Formulation of Rebamipide in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This is a randomized, open label, multiple dose, crossover study to compare the safety and Pharmacokinetics (PKs) between two rebamipide formulations after multiple oral doses of rebamipide SR 150 mg and rebamipide IR 100 mg in healthy adult volunteers.

Official Title
-----------------
A Randomized, Open Label, Multiple Dose, Crossover Study to Compare the Safety and Pharmacokinetics Between Rebamipide Sustained Release (SR) 150mg and Rebamipide Immediate Release (IR) 100mg in Healthy Volunteers

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: Rebamipide SR 150mg
* Drug: Rebamipide IR 100mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who give consent to voluntary participation by signing the informed consent form Healthy adult males aged ≥19 and ≤45 years at screening Subjects with weight ≥50 kg AND body mass index (BMI) ≥18.0 and ≤27.0 Exclusion Criteria: Subjects with hypersensitivity to the active ingredient of the IP or other anti-ulcer agents or history of clinically significant hypersensitivity Subjects with any past history of gastrointestinal diseases which can affect the absorption of the IP Subjects who have participated in other clinical trial and received any other investigational products within 3 months before the expected date of IP administration Subjects who have taken any inducers or inhibitors of drug metabolism enzyme Subjects who have been on diets that may affect the absorption, distribution, metabolism, and excretion of a drug Subjects who donated whole blood within 2 months or underwent apheresis within 1 month prior to obtaining informed consent or who did not agree to prohibit blood donation Smokers who have smoked >10 cigarettes per day within the last 6 months Subjects with any positive result on HBsAg, hepatitis C virus (HCV) Ab, HIV Ab, and venereal disease research laboratory (VDRL) tests

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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Sequence A (RT)<br>[Sequence A (RT) & Sequence B (TR)] to receive the Investigational Product (IP) by the sequence in each period: Rebamipide IR 100 mg (R): Take one tablet each at 9 am, 3 pm and 9 pm on 1d (8d) with 150 mL of water. For 9 am dose, take under the fasting condition for ≥10 hours. Rebamipide SR 150 mg (T): Take one tablet each at 9 am and 9 pm on 1d (8d) with 150 mL of water. For 9 am dose, take under the fasting condition for ≥10 hours. | Drug: Rebamipide SR 150mg<br>* Test drug<br>Drug: Rebamipide IR 100mg<br>* Reference Drug<br>|
| Other: Sequence B (TR)<br>[Sequence A (RT) & Sequence B (TR)] to receive the Investigational Product (IP) by the sequence in each period: Rebamipide IR 100 mg (R): Take one tablet each at 9 am, 3 pm and 9 pm on 1d (8d) with 150 mL of water. For 9 am dose, take under the fasting condition for ≥10 hours. Rebamipide SR 150 mg (T): Take one tablet each at 9 am and 9 pm on 1d (8d) with 150 mL of water. For 9 am dose, take under the fasting condition for ≥10 hours. | Drug: Rebamipide SR 150mg<br>* Test drug<br>Drug: Rebamipide IR 100mg<br>* Reference Drug<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | Peak Plasma Concentration of Rebamipide | From Period1/ Day1 to Period2/Day9 | 
| AUClast of Rebamipide | Area Under the plasma concentration versus time curve last of Rebamipide | From Period1/ Day1 to Period2/Day9 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| t1/2 β of Rebamipide | Time taken for half the initial dose of Rebamipide administered to be eliminated from the body | From Period1/ Day1 to Period2/Day9 | 
| Tmax of Rebamipide | Time at which the Cmax of Rebamipide is observed | From Period1/ Day1 to Period2/Day9 | 
| AUCinf of Rebamipide | Area Under the plasma concentration versus time curve inifinite of Rebamipide | From Period1/ Day1 to Period2/Day9 |