Duodenal ulcer, gastric ulcer, reflux esophagitis, etc.
Conditions
Interventions
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. 8 male subjects and 7 female subjects per dose group; Aged 18 to 45 years old; 2. BMI 19 to 26 (including 19 and 26), and more than 50 kg weight; 3. The vital signs (body temperature, systolic blood pressure, diastolic blood pressure, pulse and respiration) at the screening: body temperature from 36.0- 37.3 degree C (including 36.0 and 37.3 degree C), 90 mm Hg systolic pressure 140 mm Hg; 50 mm Hg?diastolic pressure 90 mm Hg, 60 beats/minute pulse 100beats/min.; 4. Past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening was determined healthy and QTcF<450ms; 5. No history of allergy to proton-free pump inhibitors, no allergic reactions to other drugs, and no history of allergies to biological agents; 6. Subject is able to communicate with investigator well and comply with the protocol of the study and to understand the research program and voluntary signed informed consent form.
Exclusion criteria
Exclusion criteria: 1. History of orthostatic hypotension, gastrointestinal diseases (such as gastric ulcer, gastritis, etc.), liver disease, kidney disease (nephritis, pyelonephritis, etc.) and medical history, or other systems abnormalities(such as cardiovascular, respiratory, neuropsychiatric, blood , endocrine, etc.) and other medical history; 2. Electrolyte disorders (especially hypokalemia) with clinical significance during screening and baseline examinations; 3. History of previous clinical significant ECG abnormalities, or a family history of long QT syndrome, or a family history of sudden death; 4. Subjects with rhinitis, allergic rhinitis, repeated epistaxis, nasal deformity and abnormal nasal septum; 5. Positive drug screening test (morphine, methamphetamine, ketamine, methylene dioxyamphetamine, tetrahydrocannabinol cannabis drug); 6. Pregnant or lactating women, male or female subjects who can not take effective contraception or plan to give birth within six months; 7. Taking any drugs including acid suppressants, prescription drugs, herbal medicines, over-the-counter drugs, or/and dietary supplements (including vitamins) 2 weeks before the study; 8. Blood donation or blood loss = 400mL or participants in other clinical trials within 3 months before the study; 9. Positive result of hepatitis B or hepatitis C patients or hepatitis B virus carriers, or acquired immunodeficiency syndrome, HIV antibody positive, and syphilis test; 10. History of drug abuse or alcohol abuse 12 months before the study or evidence of alcohol abuse and excessive drinking; 11. Taking food or drink containing jaundice (such as caffeine) or that inhibit or induce liver metabolism including grapefruit, star fruit and St. John's wort within 48 hours prior to administration 48 hours before the study; 12. Smokers (more than 5 cigarette per day) 3 months before the study or refuse to quit smoking during the study; 13. Any subjects who should not participate in this trial by the judgement of the invesitigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The result of vital signs;Clinical symptoms;Laboratory outcome;ECG; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cmax;Tmax;Css-min;Css-max;CL/F;t1/2;AUCss;Percentage of time for pH more than 3, pH more than 4 or pH more than 5 within 24 hours; | — |
Countries
China
Contacts
Public ContactRui Wang, Beibei Liang
Chinese PLA General Hospital
Outcome results
None listed