Renal Insufficiency,Type 2 Diabetes
Conditions
Keywords
Efficacy, PK/PD study, Renal Insufficiency, Type 2 Diabetes
Brief summary
The purpose of the study is to investigate the pharmacokinetics/pharmacodynamics and safety of SHR3824 in Type 2 Diabetes Patients with Renal Insufficient.
Detailed description
This trial was a parallel, open-label, single dose study. The subject was divided into one of three groups according to the degree of renal Insufficiency,including normal, mild and moderate. All subjects were given SHR3824 20mg, the blood and urine samples were collected before and after dosing.
Interventions
DRUGSHR3824
All subjects were given SHR3824 20mg only one time.
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
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
No
Inclusion criteria
* with a body mass index(BMI) between 19 and 33 Kg/m2; * The estimated glomerular filtration rate (eGFR)of subjects in groups must meet the corresponding standards:mild renal insufficiency:60 to 89 ml/min/1.73m2;Moderate renal insufficiency: 30 to 59 ml/min/1.73m2. * Had signed the informed consent himself or herself voluntarily.
Exclusion criteria
* Urinary tract infections, or vulvovaginal mycotic infections * Suspected or diagnosed as kidney cancer or other malignancies in patients * Autoimmune kidney disease, history of renal transplantation, dialysis patients being treated * History of or current clinically significant medical illness as determined by the Investigator * History of clinically significant allergies, especially known hypersensitivity or intolerance to lactose * Known allergy to SHR3824,SGLT2 inhibitor analogs, or any other structural analogs * Alcohol, tobacco, drug abusers;alcohol abuse is defined as a day for regular alcohol consumption more than the following standards: beer 570 ml, light beer 750 ml, red wine 200 ml, white wine 60 ml, which including about 20g alcohol;Tobacco is defined as five or more per day. * Pregnancy or lactation women, or a fertility male or female is not willing to contraception during test. * Researchers considered that there was any situation that may cause the participants can't finish this study or bring any obvious risk to subjects.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The area under the plasma concentration-time curve (AUC) of SHR3824 | 72 hours after dosing | AUC (a measure of the body's exposure to SHR3824) will be compared between normal renal function patients and mild or moderate renal dysfunction patients |
| The maximum plasma concentration (Cmax) of SHR3824 | 72 hours after dosing | Cmax (a measure of the body's exposure to SHR3824) will be compared between normal renal function patients and mild or moderate renal dysfunction patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The number of volunteers with adverse events as a measure of safety and tolerability | 72 hours after dosing | The number of volunteers with adverse events as a measure of safety and tolerability |
Countries
China
Contacts
Primary ContactHaiyan Liu, Phd
Outcome results
None listed