Renal Insufficiency,Type 2 Diabetes Clinical Trial
Official title:
Safety and Pharmacokinetics/Pharmacodynamics of SHR3824 in Type 2 Diabetes Patients With Renal Insufficient (Open-label, Parallel-Group, Single-Dose Study)
| Verified date | June 2016 |
| Source | Jiangsu HengRui Medicine Co., Ltd. |
| Contact | Haiyan Liu, Phd |
| Phone | +86-15705155025 |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of the study is to investigate the pharmacokinetics/pharmacodynamics and safety of SHR3824 in Type 2 Diabetes Patients with Renal Insufficient.
| Status | Recruiting |
| Enrollment | 24 |
| Est. completion date | December 2017 |
| Est. primary completion date | December 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| China | Chinese people's liberation army general hospital of Chengdu military area | Chengdu | Sichuan |
| Lead Sponsor | Collaborator |
|---|---|
| Jiangsu HengRui Medicine Co., Ltd. |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The area under the plasma concentration-time curve (AUC) of SHR3824 | 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 | 72 hours after dosing | |
| Primary | The maximum plasma concentration (Cmax) of SHR3824 | 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 | 72 hours after dosing | |
| Secondary | The number of volunteers with adverse events as a measure of safety and tolerability | The number of volunteers with adverse events as a measure of safety and tolerability | 72 hours after dosing |