Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-25 @ 2:03 AM
NCT ID:
NCT03009760
Eligibility Criteria:
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
45 Years
Study:
NCT03009760
Study Brief:
Protocol Section:
NCT03009760