Pharmacodynamic Properties of CJ-12420 on Evening Dosing
Pharmacodynamic Properties of CJ-12420 on Evening Dosing
The purpose of this study is to compare and evaluate impact on pharmacodynamic
 characteristics of CJ-12420 and dexlansoprazole with evening dosing in healthy male
 volunteers
Evaluation Criteria:

 1. Pharmacokinetic Endpoints Cmax, tmax, AUClast of CJ-12420

 2. Pharmacodynamics Endpoints Time pH > 4 Time pH > 6 Integrated acidity Percent inhibition
 of integrated acidity Percent inhibition time gastric pH ≤ 4 Median pH

 3. Safety Assessments Physical examination, ECGs, vital signs (blood pressure, heart rate,
 body temperature), laboratory test (CBC, Chemistry, UA), and adverse events (AEs)
Inclusion Criteria:

 1. Healthy male volunteers aged ≥20 to ≤45 years

 2. Body mass Index (BMI) of 19 to 28kg/m2 ; and a total body weight ≥ 50kg

 3. Medically healthy without clinically significant vital signs (blood pressure in
 sitting position, heart rate)

 -  90 mmHg ≤ Systolic blood pressure (SBP) ≤ 140 mmHg

 -  50 mmHg ≤ Diastolic blood pressure (DBP) ≤ 95 mmHg

 -  45 (beats/min) ≤ Heart rate ≤ 95 (beats/min)

 4. Understand restriction during the study and voluntarily consent to participate in the
 study

 5. Consent to use the effective contraceptive methods (using abstinence, spermicide, and
 condom) and not to donate sperm during the study and until 30 days after completion of
 study

 6. Non-smoker or ex-smoker who stopped smoking for at least one year

 7. Negative H. pylori result in urea breath test (UBT)

 Exclusion Criteria:

 1. History of clinically significant diseases in the digestive, kidney, liver, nervous,
 hemato-oncologic, endocrine, respiratory, immune, psychiatric, musculoskeletal, or
 cardiovascular system and other diseases that may harm safety of the subject or may
 affect the validity of study results, in the judgment of investigator

 2. History of allergy or hypersensitivity to any drugs including serious adverse events
 from treatments such as PPI (omeprazole, rabeprazole, lansoprazole) or P-CAB

 3. History surgery that may affect absorption, distribution, metabolism, and elimination
 of the study drug or in such a medical condition, at the discretion of the principal
 investigator or sub-investigator

 4. History of use of another investigational product within 90 days prior to screening
 visit

 5. Donation of a unit of whole blood within 60 days or blood components or transfusion
 within 30 days prior to screening visit

 6. Having special diet or changes in dietary habits within 30 days prior to screening
 visit

 7. Use of prescription drug within 14 days or over-the-count (OTC) drug including herbal
 medicine within 7 days prior to screening visit

 8. Alcohol > 21 units/week

 9. Caffeinated drink intake > 5units/day

 10. Positive on urinary drug screening test or urine nicotine test

 11. Positive human immunodeficiency virus (HIV), hepatitis B, hepatitis C, or syphilis
 test

 12. Clinically significant abnormal result of liver function (serum ALT, AST or total
 bilirubin levels ≥ 1.5 times the upper limit of normal (ULN))

 13. Inability to tolerate pH catheter insertion

 14. History of symptomatic GERD, erosive esophagitis (EE), duodenal ulcer, gastric ulcer,
 Barrett's esophagus, or Zollinger-Ellison Syndrome

 15. Any other conditions which would have made the subject unsuitable for the study in the
 opinion of the investigator