The purpose of this study is to compare the pharmacokinetics and pharmacodynamics of CJ-12420
after single and multiple dose administration according to H. pylori infection.
Drug: CJ-12420 50mg(HP-)
Drug: CJ-12420 100mg(HP-)
Drug: CJ-12420 50mg(HP+)
Drug: CJ-12420 100mg(HP+)
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Full eligibility criteria for NCT03009760
Ages eligible for Study
20 Years to 45 Years
Genders eligible for Study
Accepts Healthy Volunteers
Healthy male volunteers between 20 to 45 years of age (inclusive)
Body mass index (BMI) in the range of 19~28 kg/㎡ and weighted at least 50kg
Medically healthy with no clinically significant vital signs (blood pressure in the sitting position, pulse rate)
90 mmHg ≤ systolic blood pressure ≤ 140 mmHg
50 mmHg ≤ diastolic blood pressure ≤ 95 mmHg
45 beats per minute ≤ pulse rate ≤ 95 beats per minute
Understood the requirements of the study and voluntarily consented to participate in the study
Agreed to be sexually abstinent or to use a condom or spermicide when engaging in sexual activity and not to donate sperm during the course of the study for 30 days following completion of the study
Non-smokers or non-users of nicotine-containing products for at least 1 year
[Cohort 1] H. pylori negative as determined by urea breath test and serum IgG antibody
[Cohort 2] H. pylori positive as determined by urea breath test and serum IgG
History of clinically significant gastrointestinal, renal, hepatic, neurologic, hemato-oncologic, endocrine, pulmonary, immunologic, psychiatric, musculoskeletal, or cardiovascular disease or any other condition, which in the opinion of the investigators, would jeopardize the safety of the subject or impact the validity of the study results
History of allergy or hypersensitivity to any drug, including prior serious adverse reaction to PPIs or P-CABs
Undergone surgery or in a medical condition, which in the judgment of the PI or investigators may affect absorption, distribution, metabolism or elimination of the study drug
Administered other drug(s) in other clinical study within 60 days prior to screening visit
Donated blood within 60 days or blood components within 30 days, or had been transfused plasma within 30 days prior to screening visit
On special diet or have experienced substantial changes in eating habits within 30 days prior to screening visit
Used any prescription medication within 14 days, or any other OTC medications including herbal products within 7 days prior to screening visit
Consumed over 21 units/week of alcohol
Consumed over 5 units/day of caffeine-containing beverage
Positive urine screen for drugs and/or cotinine
Positive blood screen for human immunodeficiency virus (HIV), hepatitis B or C, or syphilis
Clinically significant abnormalities of liver function tests (≥1.5 fold of normal upper limit in the level of L-alanine aminotransferase (ALT), L-aspartate aminotransferase (AST) or total bilirubin)
Unable to bear pH meter catheter insertion
History of symptomatic GERD, erosive esophagitis, duodenal ulcer, gastric ulcer, Barrett's esophagus, or Zollinger-Ellison syndrome
Clinically significant observations considered as unsuitable based on medical judgment by investigators
All locations for NCT03009760
View full eligibility
Tris trial is registered with FDA with number: NCT03009760. The sponsor of the trial is CJ HealthCare Corporation and it is looking for 16 volunteers for the current phase.
Official trial title: A Phase I , Study to Investigate Pharmacokinetics and Pharmacodynamics of Single and Multiple Dose of CJ-12420 50mg, 100mg in Helicobacter Pylori ?
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