Healthy
Conditions
Brief summary
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
Detailed description
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)
Interventions
Sponsors
HK inno.N Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time pH > 4 of CJ-12420 | 24 hours pH | intragastric pH |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUClast of CJ-12420 | up to 20 hours | The area under the plasma concentration versus time curve from time 0 to the last measurable concentration |
| Cmax of dexlansoprazole | up to 20 hours | maximum measured plasma concentraion |
| AUClast of dexlansoprazole | up to 20 hours | The area under the plasma concentration versus time curve from time 0 to the last measurable concentration |
| Cmax of CJ-12420 | up to 20 hours | maximum measured plasma concentraion |
| Median pH > 4 of CJ-12420 | 24 hours pH | intragastric pH |
| Median pH > 4 of dexlansoprazole | 24 hours pH | intragastric pH |
| Time pH > 4 of dexlansoprazole | 24 hours pH | intragastric pH |
Countries
South Korea
Outcome results
None listed