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

Ascites Clinical Trial

Official title:
A Clinical Study of Multiple-dose Pharmacokinetics of Tolvaptan Tablets Administered Orally (15mg Daily) for Consecutively 7 Days in Chinese Patients With Hepatocirrhosis

Clinical Trial Summary

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

Clinical Trial Description

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 tablet (15mg) once daily, for consecutive 7 days starting from day 1 of treatment.

4. Study duration:

Screening: 14 days in maximum; Treatment(s): 7 days; Observation: 1 day ;

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01359462
Study type Interventional
Source Otsuka Beijing Research Institute
Contact
Status Completed
Phase Phase 1
Start date April 2009
Completion date January 2010
View Details
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