duodenal ulcer
Conditions
Interventions
Group A:Take test drug first, after washout period, then take control drug, including single dose (fasting and non-fasting) and multiple dose oral administration.
Group B:Take control drug first, after washout period, then take test drug, including single dose (fasting and non-fasting) and multiple dose oral administration.
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Healthy subject; 2. 18~45 years old; 3. BMI in range of 19~24kg/m2 [BMI=weight (kg)/height 2(m2)], Great disparity is not allowed in the weight of subjects in the same batch; Male subject weight(min) >60kg, weight(max)45kg, weight(max)<55kg; 4. Blood and urine routine, liver and kidney function, blood lipid, electrolyte, blood sugar and electrocardiogram examination is normal, urine pregnancy test negative in female subjects; 5. Subject should have a strong understand of the object and require of trial, and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Allergic history for ingredients of investigator product, Allergic disease , Allergic constitution and Limiting sodium diet; 2. Participate other clinical trial in the last 3 months; 3. Used any medicine in the last 2 weeks; 4. Blood donation and Test blood donation in the last 3 month; 5. any clinical significance dieases; 6. Any history of severe disease or medical history of digestive system,cardiovascular system, Liver, kidney; 7. HIV, HCV, TP-Anti positive; 8. there is the evidence of drug abuse; 9. history of tobacco, alcohol or drug abuse history; 10. Gestation period and lactation period women, menstrual period conflict with trial; 11. Use of contraceptive drugs; 12. Patients with active infections; 13. Subject can't complete the trial because of other reasons or unsuitable to participate in the trial considered by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC0-t;Cmax;Tmax;t1/2z;CLz;Vz;AUCss;Css_min; | — |
Countries
China
Contacts
Public ContactYongping Qin; Ping Feng
Outcome results
None listed