Multiple-dose Pharmacokinetics Study of Tolvaptan Tablets in Chinese Patients With Hepatocirrhosis

Exclusion Criteria

• •1. Patients with any of the following diseases, complications or symptoms:
• •* Hepatic encephalopathy (coma degree classification note 1 Grade 2 or above);
• •* Malignant ascites;
• •* Spontaneous bacterial peritonitis;
• •* Likely to have gastrointestinal bleeding during the study period;
• •* Heart failure (NYHA Note 2 Class Ⅲ andⅣ);
• •* Anuria (daily urine output below 100mL);
• •* Dysuria induced by urinary tract stenosis, calculus, or tumor.
• •2. Patients with any of the following history:
• •* With gastrointestinal bleeding within 10 days prior to screening;
• •* With cerebrovascular accident within 1 month prior to screening;
• •* With gout attack within 1 month prior to screening;
• •* With allergy or atopy to benzodiazepine drugs (benazepril hydrochloride, etc.).
• •3. Patients whose systolic blood pressure is below 90mmHg during screening;
• •4. Patients with abnormal values in the following lab examination indicators:
• •Serum creatinine higher than 2.5 times the upper limit of normal range, serum Na+\>145mmol/L(or higher than the upper limit of normal range), serum K+\> 5.5 mmol/L, uric acid\>476µmol/L, child-Pugh score\>10
• •5. Patients ineligible for oral medication
• •6. Patients in pregnancy or lactation; female of childbearing potential not taking contraceptive measures;
• •7. Patients having taken blood products including albumin products within 4 days prior to application of investigational product;
• •8. Patients having participated in clinical trials of other drugs within 1 month prior to screening;
• •9. Patients used to participate in clinical trials of Tolvaptan and take the said drug;
• •10. Patients determined by the investigator as illegible for the study.