For hepatic cirrhosis subjects with ascites or lower extremities, to study Pharmacokinetics, pharmacology, and safety of the drug under fasting condition.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Drug: tolvaptan tablet, 15mg, Qd, for 7 days.
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
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
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
pharmacological parameter:24-hr urine
Time frame: From day-1 to day 8
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