Effect of Omeprazole on the Pharmacokinetics of SHR6390 in Healthy Subjects

Launched by JIANGSU HENGRUI MEDICINE CO., LTD. · Aug 3, 2021

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Sign the informed consent before the trial, and fully understand the trial content, process and possible adverse reactions;
• • 2. Ability to complete the study as required by the protocol;
• • 3. Healthy male or female subjects aged 18 to 45 (including 18 and 45) at the date of signing the informed consent;
• • 4. Subjects shall ake effective contraceptive measures voluntarily within 7 months from the date of signing the informed consent form to the date of the last medication. Serum HCG test of fertile women before the study must be negative;
• • 5. Male body weight ≥ 50 kg, female body weight ≥ 45 kg, and body mass index (BMI) within the range of 19 \~ 26 kg /m2 (including 19 and 26);
• • 6. Healthy subjects identified by a detailed medical history;
• • 7. Full physical examinations, including blood pressure and pulse rate measurement, 12-lead ECG or clinical laboratory test, are normal or abnormal but have no clinical significance.
• Exclusion Criteria:
• • 1. Blood donation or loss≥400 mL within 3 months prior to screening, or blood donation or loss≥200 mL, or blood transfusion within 1 months before screening;
• • 2. Participating in any clinical trial or taking drugs that might damage organs within 3 months before screening;
• • 3. Surgeries in the previous 6 months before screening;
• • 4. Use of vaccines or biologicals within 2 weeks prior to screening;
• • 5. Allergic constitution;
• • 6. History of drug abuse or alcoholism, or positive for nicotine, alcohol and drug tests;
• • 7. History of myocarditis, coronary heart disease, arrhythmia, stroke and so on, or 12 lead ECG demonstrating a corrected QT by Fridericia (QTcF) interval ≥450 msec;
• • 8. With dysphagia or history of gut disease or surgery (gastrectomy, enterectomy, sleeve gastrectomy, etc) possibly affecting drug absorption;
• • 9. Uncontrolled gut disease, such as peptic ulcer, colitis, pancreatitis, etc;
• • 10. History of chronic kidney disease, renal insufficiency, anemia of renal failure, or creatinine clearance rate (CLCr) \< 80 mL/min, or serum creatinine ≥ ULN.