Erectile Dysfunction, Pulmonary Arterial Hypertension
Conditions
Keywords
TPN171H, renal insufficiency, Pharmacokinetics
Brief summary
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
Detailed description
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.
Interventions
DRUGTPN171H single dose
10 mg TPN171H taken once
Sponsors
Shanghai Institute of Materia Medica, Chinese Academy of Sciences
Vigonvita Life Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age 18-70 years old, both male and female; 2. Weight: male ≥ 50 kg, female ≥ 45 kg, 18 kg/m2 ≤ BMI ≤ 30 kg/m2 ; 3. Healthy subjects meet: GFR ≥ 90ml / min and \< 130ml / min; the GFR of the subjects in the corresponding group meet the criteria of MDRD in the stage of renal function. Mild renal insufficiency (CKD 2 stage) : GFR : 60-89 mL/min; moderate renal insufficiency (CKD 3 stage) : GFR : 30-59mL/min; Severe renal insufficiency (CKD 4): GFR: 15-29 mL/min; renal failure (CKD 5) : GFR\<15 mL/min； 4. Be able to understand the procedures and methods of this study, be willing to strictly abide by the clinical trial scheme, complete this trial, and voluntarily sign the informed consent.
Exclusion criteria
* Common
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the curve (AUC) | 72 hours or 120 hours after dosing | Area under the curve (AUC) for plasma and urine following a single dose of TPN171H in subjects with renal insuffiency and healthy subjects. |
| Time to maximum plasma concentration (Tmax) | 72 hours or 120 hours after dosing | Time to maximum plasma concentration (Tmax) for plasma and urine following a single dose of TPN171H in subjects with renal insuffiency and healthy subjects. |
| Maximum plasma concentration (Cmax) | 72 hours or 120 hours after dosing | Maximum plasma concentration (Cmax) for plasma and urine following a single dose of TPN171H in subjects with renal insuffiency and healthy subjects. |
| Terminal half-life (t 1/2) | 72 hours or 120 hours | Terminal half-life (t 1/2) for plasma and urine following a single dose of TPN171H in subjects with renal insuffiency and healthy subjects. |
| Apparent distribution volume (Vd) | 72 hours or 120 hours after dosing | Apparent distribution volume (Vd) for plasma and urine following a single dose of TPN171H in subjects with renal mpairment and healthy subjects. |
| Clearance rate (CL) | 72 hours or 120 hours after dosing | Clearance rate (CL) for plasma and urine following a single dose of TPN171H in subjects with renal insuffiency and healthy subjects. |
| Oral bioavailability (F) | 72 hours or 120 hours after dosing | Oral bioavailability (F) for plasma and urine following a single dose of TPN171H in subjects with renal insuffiency and healthy subjects. |
| Adverse events | From administration of study drug through 8 days after administration of study drug | Number of Participants With treatment-related Adverse Events and Serious Adverse Events. |
Countries
China
Outcome results
None listed