Healthy
Conditions
Keywords
Food-Effect, Pharmacokinetics, Pharmacodynamics
Brief summary
* Primary: To evaluate food effect on the pharmacokinetics (PK) of a single oral dose of CJ-12420 in healthy male subjects. * Secondary * To explore food effect on the pharmacodynamics (PD) of single oral dose of CJ-12420 in healthy male subjects(PD/PK group) * To evaluate the safety of single oral dose of CJ-12420 in healthy male subjects under fed or fasting condition.
Interventions
DRUGCJ-12420 200mg
Period1: CJ-12420 200mg fed condition Period2: CJ-12420 200mg fasting condition Period1: CJ-12420 200mg fasting condition Period2: CJ-12420 200mg fed condition
Sponsors
HK inno.N Corporation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Male volunteers in the age between 20 and 45 years old(inclusive) * Body mass index (BMI) in the range of 19 to 28 kg/m2 and weighing at least 50 kg (inclusive) * Medically healthy with no clinically significant vital signs (sitting position blood pressure, pulse rate) 1. 90 mmHg ≤ systolic blood pressure ≤ 140 mmHg 2. 50 mmHg ≤ diastolic blood pressure ≤ 95 mmHg 3. 45 beats per minute ≤ pulse rate ≤ 95 beats per minute * Understand the requirements of the study and voluntarily consent to participate in the study
Exclusion criteria
Subjects will be excluded from the study if there is evidence of any of the following criteria: Last three criteria will be applied ONLY to PD/PK group. * History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary,immunologic, psychiatric, musculoskeletal or cardiovascular disease or any other condition, which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results * History of allergy or sensitivity to any drug, including any prior serious adverse reaction to PPIs (e.g. omeprazole, rabeprazole, lansoprazole) * History of symptomatic GERD, erosive esophagitis, duodenal ulcer, gastric ulcer, Barrett's esophagus or Zollinger-Ellison syndrome, previous positive H. pylori The following criteria will be applied ONLY to PD/PK group * H.pylori positive, as determined by the urea breath test * Urine cotinine test positive * Subject who were unable to be applicable for pH meter catheter
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Geometric mean ratio and 90% CI for log-transformed AUClast | Blood sampling during 24 or 48 hrs after administration |
| Geometric mean ratio and 90% CI for log-transformed Cmax | Blood sampling during 24 or 48 hrs after administration |
Secondary
| Measure | Time frame |
|---|---|
| time pH > 4 | 24 hour before and after IP administration |
Countries
South Korea
Outcome results
None listed