SHR3824 is a novel inhibitor of renal sodium-glucose cotransporter 2, allows an insulin-independent approach to improve type 2 diabetes hyperglycemia. In this multiple-dose study the investigators evaluated the safety, tolerability and PK/PD profiles of SHR3824 in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
48
Shanghai Xuhui Central Hospital
Shanghai, Shanghai Municipality, China
AUC(Area under the curve) of SHR3824.
Time frame: day1 and day11 to day 13.
Cmax(the maximum concentration) of SHR3824.
Time frame: day1 and day11 to day 13.
Tmax(the time reaching maximum concentration) of SHR3824.
Time frame: day1 and day11 to day 13.
Halflife of SHR3824.
Time frame: day1 and day11 to day 13.
CL/F of SHR3824.
Time frame: day1 and day11 to day 13.
V/F of SHR3824.
Time frame: day1 and day11 to day 13.
Accumulation ratio of SHR3824
Time frame: Up to day 13.
Urine glucose concentration of SHR3824.
Time frame: day1 and day11
Plasma glucose concentration of SHR3824.
Time frame: day1 and day11
Adverse events, vital signs, physical exams , ECG, clinical labs
Time frame: Days -14 to -1, 0, 13.
Serum creatinine
Time frame: Days -14 to -1, 0, 2, 9, 13.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.