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

Inclusion Criteria:

1. Hepatic Cirrhosis with ascites or lower extremities edema
2. Hospitalized patients
3. 18 years old~75 years old
4. Inform Consent Form Signed

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.