None listed
Conditions
Sponsors
DaehanNupharm
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Healthy adults aged 19 to 55 at the time of screening test 2) Those who weigh not less than 50.0 kg and not more than 90.0 kg and have a BMI of not less than 18.0 kg/m2 but not more than 28.0 kg/m2 at the time of screening test ? Body mass index (kg/m2) = Weight (kg)/[Height (m)]2 3) Those who were tested negative for serum Helicobacter pylori anibody 4) A person who has heard and fully understood this clinical trial and has voluntarily decided to participate and has agreed in writing to comply with the precautions 5) A person who is suitable as a test subject when judging a tester through physical examination, clinical laboratory examination, questionnaire, etc
Exclusion criteria
Exclusion criteria: 1) A person who has or has a history of diseases corresponding to clinically significant hepatabiliary system, kidney, nervous system, immune system, respiratory system, digestive system, endocrine system, blood • tumor, cardiovascular system, urinary system, psychiatric disease, etc 2) A person who has a history of hypersensitivity to drugs and other drugs (aspirin, antibiotics, etc.) containing the same family, or of clinically significant hypersensitivity reactions 3) Gastrointestinal diseases (gastrointestinal ulcers, gastritis, gastric cramps, gastroesophageal reflux disease, Crohn's disease, etc.) that may affect the safety and pharmacokinetic evaluation of clinical trial drugs (except simple appendectomy, hernia surgery) 4) A person who has shown the following results in a screening test - Blood AST (SGOT), ALT (SGPT) > Normal Range Upper Limit × 1.5 - Serum test (Hepatitis B test, Hepatitis C test, Human Immunodeficiency Virus (HIV) test) results positive 5) Those who are unable to insert and maintain the pH monitor catheter due to anatomical problems 6) A person who has a history of drug abuse or has tested positive for an abused drug in a urine screening test 7) A person who has taken a specialized drug within two weeks prior to the first scheduled date of administration of a clinical trial drug, or has taken any general drug, health functional food, vitamin preparation or herbal medicine within one week, or is expected to be taken 8) A person who has taken a drug metabolite enzyme-induced and inhibitory drug, such as a barbiturate drug, within one month prior to the first scheduled administration of a drug for clinical trials 9) Participants in other clinical trials (including biological equivalence tests) within 6 months prior to the scheduled date of the first administration of the clinical trial drug 10) Blood transfusion within two months before the first administration of the clinical trial drug, or component blood donation within one month, or blood transfusion within one month before the first administration of the clinical trial drug the recipient 11) Continuous drinking (above 21 units/week, 1 unit = 10 g of pure alcohol) or during the period from 3 days prior to the scheduled date of the first administration of the clinical trial drug to the last discharge an irresistible person 12) A current smoker or a person who is unable to stop smoking for a period from three months prior to the scheduled first administration of clinical trial drugs to the last discharge 13) A person who is unable to consume grapefruit-containing food during the period from three days prior to the scheduled first administration of clinical trial drugs to the last discharge 14) A person who has a unique eating habit (e.g. intake of grapefruit-containing beverages per day, continuous vegetarian eating habits, etc.) or is unable to eat the meals provided in this clinical trial 15) Caffeine/caffeine-containing foods (coffee, tea, soda, etc.) for a period from 3 days prior to the expected first administration date to the last discharge, A person who is unable to prohibit the consumption of coffee milk, energy tonic drinks, etc.) 16) Appropriate double contraception or medically recognized by you, your spouse or partner during the pre-clinical trial period and at least four weeks after the administration of the last clinical trial drug A person who is unable to use acceptable contraception and who does not agree to donate sperm u
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Safety evaluation 1) Abnormal reactions such as self-awareness or percussion symptoms 2) Physical examination 3) Vital signs 4) ECG examination 5) Clinical laboratory examination (hematological examination, blood chemistry examination, urinary examination) | — |
Primary
| Measure | Time frame |
|---|---|
| 24h monitored intragastric pH;plasma concentration | — |
Countries
Korea, Republic of
Contacts
Public ContactSeungHwan Lee
Seoul National University Hospital
Outcome results
None listed