To evaluate the effect of renal insufficiency on the pharmacokinetics of TPN171H tablets after single dose oral administration, so as to provide basis for formulating clinical medication plan for patients with renal insufficiency; To evaluate the safety of TPN171H tablets in patients with renal insufficiency and healthy subjects
The study design of two centers, parallel, open and single dose administration is adopted. The experiment is carried out in two stages, whether or not to start the second stage is according to the test results of the first stage. The first stage: there are two groups: severe renal insufficiency group and healthy subjects group. 8 subjects in each group (both male and female), a total of 16 cases. The second stage: part A or part B. Part A: there are two groups: non dialysis end-stage renal disease (ESRD) group, with 8 subjects (both men and women), in the group with healthy subjects , there are 0-8 subjects. Part B: there are three groups: mild renal insufficiency, moderate renal insufficiency and healthy subjects. There are 8 subjects (both male and female) in both mild renal insufficiency group and moderate renal insufficiency group, and 0-8 subjects (both male and female) in the healthy subjects group. The initiation criteria of second stage study are: if auc0-t of subjects with severe renal insufficiency in the first stage is less than twice that of subjects with healthy subjects, And expected in the end of nephropathy If there is no significant increase in safety risk among (non dialysis) subjects, it is decided to start the second stage part A study instead of the second stage part B study according to the results of the first stage; if the auc0-t of subjects with severe renal insufficiency in the first stage is more than twice that of subjects with healthy subjects, it is decided whether to start the second stage part B study instead of the second stage part A study according to the results of the first stage.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
10 mg TPN171H taken once
West China Hospital
Chengdu, Sichuan, China
Chengdu Xinhua Hospital
Chengdu, Sichuan, China
Area under the curve (AUC)
Area under the curve (AUC) for plasma and urine following a single dose of TPN171H in subjects with renal insuffiency and healthy subjects.
Time frame: 72 hours or 120 hours after dosing
Time to maximum plasma concentration (Tmax)
Time to maximum plasma concentration (Tmax) for plasma and urine following a single dose of TPN171H in subjects with renal insuffiency and healthy subjects.
Time frame: 72 hours or 120 hours after dosing
Maximum plasma concentration (Cmax)
Maximum plasma concentration (Cmax) for plasma and urine following a single dose of TPN171H in subjects with renal insuffiency and healthy subjects.
Time frame: 72 hours or 120 hours after dosing
Terminal half-life (t 1/2)
Terminal half-life (t 1/2) for plasma and urine following a single dose of TPN171H in subjects with renal insuffiency and healthy subjects.
Time frame: 72 hours or 120 hours
Apparent distribution volume (Vd)
Apparent distribution volume (Vd) for plasma and urine following a single dose of TPN171H in subjects with renal mpairment and healthy subjects.
Time frame: 72 hours or 120 hours after dosing
Clearance rate (CL)
Clearance rate (CL) for plasma and urine following a single dose of TPN171H in subjects with renal insuffiency and healthy subjects.
Time frame: 72 hours or 120 hours after dosing
Oral bioavailability (F)
Oral bioavailability (F) for plasma and urine following a single dose of TPN171H in subjects with renal insuffiency and healthy subjects.
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Time frame: 72 hours or 120 hours after dosing
Adverse events
Number of Participants With treatment-related Adverse Events and Serious Adverse Events.
Time frame: From administration of study drug through 8 days after administration of study drug