The purpose of the study is to investigate the potential interaction between multiple oral doses of SHR3824 and multiple oral doses of SP2086 in healthy adult volunteers.
This is an open-label (volunteers will know the names of treatments they are assigned) single-center study of SHR3824 and SP2086 in healthy adult volunteers. SHR3824(a Sodium-Glucose Cotransporter 2 inhibitor) is currently under development to lower blood sugar levels in patients with type 2 diabetes mellitus (T2DM) ,and SP2086(a Dipeptidyl peptidase IV inhibitor) is also currently under development to lower blood sugar levels in patients with type 2 diabetes mellitus (T2DM).SP2086 will be administered orally (by mouth) as 100mg on Days 1, 2, 3, 4, 15, 16, 17 and 18, SHR3824 will be administered orally (by mouth) as 20mg on Days 11, 12, 13, 14, 15, 16, 17 and 18. Both SHR3824 and SP2086 tablets will be taken with 8 ounces (240 mL) of water.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
One 100-mg tablet of SP2086 once daily on Day 1,2,3,4 followed by two 10-mg tablets of SHR3824 once daily on Day 11,12,13,14, followed by one 100-mg tablet of SP2086 and two 10-mg tablets of SHR3824 on Day 15,16,17,18.
Phase I Unit of Tongji Hospital affilated Tongji Medical School of Huangzhong Science and Thechnology
Wuhan, Hubei, China
RECRUITINGThe maximum plasma concentration (Cmax) of SHR3824.
Cmax (a measure of the body's exposure to SHR3824) will be compared before and after administration of multiple doses of SP2086.
Time frame: At protocol-specified times up to Day 14 and Day 18.
The area under the plasma concentration-time curve (AUC) of SHR3824.
AUC (a measure of the body's exposure to SHR3824) will be compared before and after administration of multiple doses of SP2086.
Time frame: At protocol-specified times up to Day 14 and Day 18.
The maximum plasma concentration (Cmax) of SP2086.
Cmax (a measure of the body's exposure to SP2086) will be compared. before and after administration of multiple doses of SHR3824
Time frame: At protocol-specified times up to Day 4 and Day 18.
The area under the plasma concentration-time curve (AUC) of SP2086.
AUC (a measure of the body's exposure to SP2086) will be compared before and after administration of multiple doses of SHR3824.
Time frame: At protocol-specified times up to Day 4 and Day 18.
The number of volunteers with adverse events as a measure of safety and tolerability.
Time frame: Up tp day 18.
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