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

Launched by OTSUKA BEIJING RESEARCH INSTITUTE · May 23, 2011

Keywords

ClinConnect Summary

This study is to evaluate the multiple-dose pharmacokinetics, pharmacological actions and safety of Tolvaptan tablets administered orally (15 mg daily) for consecutively 7 days in Chinese adult patients with confirmed Child-Pugh Class B（score 7-9） hepatocirrhosis (accompanied by ascites).

Trial Design:

1. Open, single-center, multi-dose pharmacokinetics study
2. Study population:

Chinese adult patients with confirmed Child-Pugh Class B (score 7-9) hepatocirrhosis (accompanied by ascites)
3. Dosage and mode of administration of investigational product:

Oral administration of 1 tabl...

Gender

ALL

Eligibility 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.