peptic ulcer hemorrhage
Conditions
Interventions
Group 1:5 mg of H008 injection, 40 mg of QD or Esomeprazole sodium for injection, 5 mg of BID or placebo, QD
Group 2:H008 injection 10 mg, QD or injection of Esomeprazole sodium 40 mg, BID or placebo 10 mg, QD
Group 3:H008 injection 20 mg or H008 tablet 20 mg
Group 4:H008 injection 40 mg, QD or injection of Esomeprazole sodium 40 mg, BID or placebo 40 mg, QD
Group 5:H008 injection 50 mg, QD or injection of Esomeprazole sodium 40 mg, BID or placebo 50 mg, QD
Sponsors
Zhejiang Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Healthy adult subjects aged 18-45 years old (including 18 and 45 years old), male and female (healthy refers to normal or abnormal results of medical history inquiry, physical examination, vital signs examination, laboratory examination and 12-lead electrocardiogram, but not clinically significant as judged by the investigator); 2. Weight >= 50.0 kg for males and >= 45.0 kg for females, and body mass index (BMI): 19.0-26.0 kg/m2 (including 19.0 and 26.0, BMI = weight/height2); 3. Subjects voluntarily sign informed consent; 4. Subjects should take appropriate contraceptive measures from 2 weeks before screening to 3 months after drug discontinuation to avoid pregnancy for themselves or their partners; 5. The subjects have a good life schedule and can maintain good communication with the researchers and comply with various requirements of the clinical trial.
Exclusion criteria
Exclusion criteria: 1. History of clinically significant drug allergy or history of atopic allergic diseases (such as asthma, urticaria, eczematous dermatitis, etc.) Hypersensitivity to prazole, lansoprazole, ilaprazole, esomeprazole, rabeprazole, etc.); 2. Any disease or medical history that may significantly affect drug absorption, distribution, metabolism and excretion, or any condition that may pose a hazard to the subject. like: (1) Patients with inflammatory bowel disease, gastric ulcer, duodenal ulcer, gastrointestinal/rectal bleeding, persistent nausea or other clinically significant gastrointestinal abnormalities; (2) There is a history of major gastrointestinal surgery in the past (such as: gastrectomy, gastrointestinal anastomosis, intestinal resection, gastric bypass surgery, gastric division or gastric bag banding, cholecystectomy, but appendicitis surgery and prolapse); (3) Evidence of liver disease or clinically significant liver function impairment (such as AST, ALT or total bilirubin > 1.5 times ULN) at the time of screening; (4) There is a history or evidence of renal disease or renal insufficiency at the time of screening (such as creatinine clearance (CrCl = 400 mL within 3 months before the test, or blood donation during the planned period of taking the drug and within 3 months after stopping the drug; 10. Those who have taken drugs within 3 months before the test or have a history of drug abuse within 12 months, or have a positive urine drug screening during screening; 11. Those who have been vaccinated within 3 months before the trial and those who plan to be vaccinated within 3 months after the trial; 12. Participate in any other clinical trials and take drugs within 3 months before the trial; 13. Difficulty in blood collection, those who cannot tolerate venipuncture, or those who have a history of fainting of needles and blood; those who cannot tolerate gastric intubation; 14. Pregnant or lactating women; 15. Those who have special requirements for diet; 16. Other conditions considered by the researcher to be inappropriate to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK parameters;PD index;Safety Specifications;Bioavailability; | — |
Countries
China
Contacts
Public ContactPing Huang
Jiangsu Carephar Pharmaceutical Co., Ltd
Outcome results
None listed