Safety and Pharmacokinetics/Pharmacodynamics of SHR3824 in Type 2 Diabetes Patients With Renal Insufficient

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to investigate the pharmacokinetics/pharmacodynamics and safety of SHR3824 in Type 2 Diabetes Patients with Renal Insufficient.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Criteria

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.