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:
2025-12-24 @ 6:41 PM
Ignite Modification Date:
2025-12-24 @ 6:41 PM
NCT ID:
NCT04066257
Eligibility Criteria:
Inclusion Criteria:
* Healthy adult aged ≥ 19 and \< 55 year-old on the day of obtaining the informed consent.
* Body mass index (BMI) ≥ 17.5 kg/m2 and \< 28.0 kg/m2 with a body weight ≥ 55 kg at screening.
* H. pylori negative.
Exclusion Criteria:
* Medical History
1. History or evidence of clinically significant disease
2. History of gastrointestinal disease (e.g., esophageal disease such as esophageal achalasia or stenosis, and Crohn's disease) or surgery that may affect the absorption of a drug.
3. History or presence of hypersensitivity to IMPs, components of IMPs, benzimidazoles, imidazole derivatives or tetracycline antibiotics
* Laboratory tests(in blood)
1\) Total bilirubin, AST (GOT), ALT (GPT) \> 1.5 X upper limit of normal (ULN) at screening
* History of drug/alcohol abuse
* Participated in other study and received investigational product within 3 months prior to the first study dose.
* taken a medication known to substantially induce or inhibit a drug metabolizing enzyme
* Not able to use a medically acceptable contraceptive method throughout the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
55 Years
Study:
NCT04066257
Study Brief:
Protocol Section:
NCT04066257