Gastric ulcer, duodenal ulcer, stress ulcer, reflux esophagitis and Zhuo-Ai syndrome (gastrin)
Conditions
Interventions
Fasting group-A:Phase I: the test preparation (T)
Phase II: the reference preparation (R)
Fasting group-B:Phase I:the reference preparation (R)
Phase II: the test preparation (T)
Postprandial group-A:T-R-R
Postprandial group-B:R-T-R
Postprandial group-C:R-R-T
Sponsors
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects who meet all of the following conditions enter the trial 1) Aged = 18 years, male and female; 2) The male subject has a body weight = 50.0 kg, the female subject has a body weight = 45.0 kg, and the body mass index (BMI) is between 19 and 26 kg/m 2; 3) Subjects voluntarily sign written informed consent; 4) Subjects are able to communicate well with the investigator and are able to follow the study protocol to complete the trial.
Exclusion criteria
Exclusion criteria: Subjects who meet one of the following conditions will not be eligible for the trial. 1) Any clinically serious disease, such as the circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry, and metabolic abnormalities, or any other disease that can interfere with the test results; 2) A history of allergies to drugs, food or other substances; 3) Those who have undergone surgery within 4 weeks prior to the trial or who plan to undergo surgery during the study; 4) Those who have taken any medicines or health products (including Chinese herbal medicines) within 14 days before the test; 5) Any drug that inhibits or induces liver metabolism of the drug within 30 days prior to the test (eg, inducer - barbiturate, carbamazepine, phenytoin, glucocorticoid, omeprazole; inhibitor - SSRI resistance) Depressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines; 6) Take any clinical trial drug or participate in any drug clinical trial within 3 months before the trial; 7) Blood donors within 3 months before the test; 8) Pregnant or lactating women, or who cannot use one or more non-pharmaceutical contraceptives during the trial; 9) Those who have special requirements for diet and cannot follow the unified diet; 10) Drink excessive amounts of tea, coffee and/or caffeinated beverages (8 cups or more, 1 cup = 250 mL) per day; 11) Smokers or smokers with more than 5 cigarettes per day for 3 months before the test and those who cannot be smoked during the hospitalization observation period; 12) Alcoholics or those who regularly drink alcohol within 6 months prior to the test, ie drinking more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine); 13) Drug abusers or those who have used soft drugs (such as marijuana) 3 months before the test or hard drugs (such as cocaine, phencyclidine, etc.) 1 year before the test; 14) Abnormal vital signs (systolic blood pressure 140 mmHg, diastolic blood pressure 90 mmHg; pulse/heart rate 100 bpm) or physical examination, electrocardiogram, laboratory examination abnormalities have clinical significance (subject to the judgment of the clinician); 15) Subjects may not be able to complete the study for other reasons or those the investigator believes should not be included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Omeprazole blood concentration; | — |
Countries
China
Contacts
Public ContactGuoPing Yang
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Outcome results
None listed