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

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

For hepatic cirrhosis subjects with ascites or lower extremities, to study Pharmacokinetics, pharmacology, and safety of the drug under fasting condition.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Beijing Research Institute
• Treatments: Tolvaptan

Criteria

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.