Pharmacodynamic Properties of CJ-12420 on Evening Dosing

Evaluation Criteria:

• Pharmacokinetic Endpoints Cmax, tmax, AUClast of CJ-12420
• Pharmacodynamics Endpoints Time pH > 4 Time pH > 6 Integrated acidity Percent inhibition of integrated acidity Percent inhibition time gastric pH ≤ 4 Median pH
• Safety Assessments Physical examination, ECGs, vital signs (blood pressure, heart rate, body temperature), laboratory test (CBC, Chemistry, UA), and adverse events (AEs)

Inclusion criteria

• Healthy male volunteers aged ≥20 to ≤45 years
• Body mass Index (BMI) of 19 to 28kg/m2 ; and a total body weight ≥ 50kg
• 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)
• Understand restriction during the study and voluntarily consent to participate in the study
• 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
• Non-smoker or ex-smoker who stopped smoking for at least one year
• Negative H. pylori result in urea breath test (UBT)

Exclusion criteria

• 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
• History of allergy or hypersensitivity to any drugs including serious adverse events from treatments such as PPI (omeprazole, rabeprazole, lansoprazole) or P-CAB
• 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
• History of use of another investigational product within 90 days prior to screening visit
• Donation of a unit of whole blood within 60 days or blood components or transfusion within 30 days prior to screening visit
• Having special diet or changes in dietary habits within 30 days prior to screening visit
• Use of prescription drug within 14 days or over-the-count (OTC) drug including herbal medicine within 7 days prior to screening visit
• Alcohol > 21 units/week
• Caffeinated drink intake > 5units/day
• Positive on urinary drug screening test or urine nicotine test
• Positive human immunodeficiency virus (HIV), hepatitis B, hepatitis C, or syphilis test
• Clinically significant abnormal result of liver function (serum ALT, AST or total bilirubin levels ≥ 1.5 times the upper limit of normal (ULN))
• Inability to tolerate pH catheter insertion
• History of symptomatic GERD, erosive esophagitis (EE), duodenal ulcer, gastric ulcer, Barrett's esophagus, or Zollinger-Ellison Syndrome
• Any other conditions which would have made the subject unsuitable for the study in the opinion of the investigator