Repeated Dosing Clinical Trial of HL151
Repeated Dosing Clinical Trial of HL151
The purpose of this study is to assess the pharmacokinetic characteristics of bepotastine
 after multiple oral administration of TALION tab., a IR formulation of bepotastine as
 reference drug and HL151, a SR formulation of bepotastine as test drug in healthy male
 adults. Additionally the safety and tolerability of two drugs will be evaluated.
Inclusion Criteria:

 1. Healthy male in the age of 19-45

 2. Body weight ≥ 50kg, BMI 18~29 kg/m2

 3. Subject who sign on an informed consent form willingly

 Exclusion Criteria:

 1. Subject with serious active cardiovascular, respiratory, hepatologic, renal,
 hematologic, gastrointestinal, immunologic, dermal, neurologic, or psychological
 disease or history of such disease

 2. Subject with acute disease within 28 days prior to study medication dosing

 3. Subject with known for history of disease which affect on the absorption,
 distribution, metabolism, excretion of drug

 4. Subject with clinically significant chronic disease

 5. Positive on the test of HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL

 6. Use of any prescription medication within 14 days prior to study medication dosing

 7. Use of any medication such as over-the-counter medication including oriental
 medication within 7 days prior to study medication dosing

 8. Subject with clinically significant allergic disease

 9. Subject with known for hypersensitivity reaction to bepotastine

 10. Subject with any of the following conditions in laboratory test

 -  AST/ALT > UNL (upper normal limit) x 2

 -  Total bilirubin > UNL x 2

 -  Renal failure with CLcr < 50mL/min calculated on Cockcroft-Gault [Cockcroft-Gault
 GFR = (140-age) * (Wt in kg) / (72 *Cr)]

 -  SBP<100mmHg or ≥160mmHg, DBP<60mmHg or ≥100mmHg

 -  QTc>440msec on ECG

 -  Serum potassium < 3.5 mEq/L or > 5.5 mEq/L

 11. Immunological incompetence, immune deficiency or taking immunosuppressants

 12. Subject who cannot take standard meal

 13. Subject with whole blood donation within 60days, component blood donation within
 20days prior to study medication dosing

 14. Subject with blood transfusion within 30days prior to study medication dosing

 15. Participation in any clinical investigation within 90days prior to study medication
 dosing

 16. Continued excessive use of caffeine (caffeine >five cups/day),
 alcohol(alcohol>30g/day) and severe heavy smoker(cigarette >10 cigarettes per day)

 17. Subject with decision of nonparticipation through investigator's review due to
 laboratory test results or other excuse such as non-responding to request or
 instruction by investigator

 18. Subject taking inducer or inhibitor of drug metabolism enzyme such as barbital within
 30days prior to study medication dosing

 19. Subject who are not using adequate means of contraception

 20. Subject with genetic problems such as galactose intolerance, Lapp Lactase Deficiency
 or glucose-galactose malabsorption

 21. Subject with history of drug abuse or drug addiction