NCT01359462

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Otsuka Beijing Research Institute · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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

Conditions

• Hepatic Cirrhosis
• Ascites

Interventions

Type	Name	Description
DRUG	tolvaptan	Drug: tolvaptan tablet, 15mg, Qd, for 7 days.

Timeline

• Start date: 2009-04-01
• Primary completion: 2009-11-01
• Completion: 2010-01-01
• First posted: 2011-05-24
• Last updated: 2011-05-24

Locations

1 site across 1 country: China