Multiple-dose Pharmacokinetics Study of Tolvaptan Tablets in Chinese Patients With Hepatocirrhosis
For hepatic cirrhosis subjects with ascites or lower extremities, to study Pharmacokinetics, pharmacology, and safety of the drug under fasting condition.
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Serum concentration of tolvaptan and its metabolites DM-4103 and DM-4107 [ Time Frame: blood sample will be collected at predose, 2,4,6,8,12,24 hour of first drug administration and predose of sixth drug administration and predose,2,4,6,8,12,24 hour of seventh drug administration ] [ Designated as safety issue: No ]
- pharmacological parameter:Serum concentration of sodium and potassium [ Time Frame: Blood sample will be collected at predose on day1;12,24hour of first dosing;before breakfast on day3 to day6;predose and 12,24hour of seventh dosing ] [ Designated as safety issue: No ]
- pharmacological parameter:24-hr urine [ Time Frame: From day-1 to day 8 ] [ Designated as safety issue: No ]
|Study Start Date:||April 2009|
|Study Completion Date:||January 2010|
|Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
|Experimental: Tolvaptan 15mg tablet||
tablet, 15mg, Qd, for 7 days.
Other Name: SAMSCA
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).
- Open, single-center, multi-dose pharmacokinetics study
Chinese adult patients with confirmed Child-Pugh Class B (score 7-9) hepatocirrhosis (accompanied by ascites)
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.
- Study duration:
Screening: 14 days in maximum; Treatment(s): 7 days; Observation: 1 day
Please refer to this study by its ClinicalTrials.gov identifier: NCT01359462
|Renji Hospital, Shanghai Jiao Tong University School of Medicine|
|Shanghai, Shanghai, China, 200001|
|Principal Investigator:||Minde Zeng||Renji hospital, Shanghai Jiaotong University School of Medicine|