The purpose of the study is to investigate the potential interaction between SP2086 and Glyburide after the singe and multiple oral doses treatment in healthy adult volunteers respectively.
This is an open-label (volunteers will know the names of treatments they are assigned) single-center and cross-over study of SP2086 and Glyburide in healthy adult volunteers. All subject were randomized into two groups, and the drugs will be administered according to the AB and BA sequences.The A sequence was that Glyburide was taken at 5mg qd dose on Days1,4,5,6,7 and 8; SP2086 will be administered orally (by mouth) as 200mg on Days 8.The B sequence was that SP2086 was taken at 200mg qd dose on Days1,4,5,6,7 and 8; Glyburide will be administered orally (by mouth) as 200mg on Days 8.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
In the A sequence Glyburide was taken at 5mg qd dose on Days1,4,5,6,7 and 8; SP2086 will be administered orally (by mouth) as 200mg on Days 8.In the B sequence was that SP2086 was taken at 200mg qd dose on Days1,4,5,6,7 and 8;Glyburide will be administered orally (by mouth) as 200mg on Days 8.
In the A sequence Glyburide was taken at 5mg qd dose on Days1,4,5,6,7 and 8; SP2086 will be administered orally (by mouth) as 200mg on Days 8.In the B sequence was that SP2086 was taken at 200mg qd dose on Days1,4,5,6,7 and 8;Glyburide will be administered orally (by mouth) as 200mg on Days 8.
Qilu Hospital of Shandong University
Jinan, Shandong, China
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 SP2086
Time frame: up to Day 25
The maximum plasma concentration (Cmax) of SP2086 acid
Cmax (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of multiple doses of SP2086
Time frame: up to Day 25
The maximum plasma concentration (Cmax) of Glyburide
Cmax (a measure of the body's exposure to Glyburide) will be compared before and after administration of multiple doses of Glyburide
Time frame: up to Day 25
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 SP2086
Time frame: up to Day 25
The area under the plasma concentration-time curve (AUC) of SP2086 acid
AUC (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of multiple doses of SP2086
Time frame: up to Day 25
The area under the plasma concentration-time curve (AUC) of Glyburide
AUC (a measure of the body's exposure to Glyburide) will be compared before and after administration of multiple doses of Glyburide
Time frame: up to Day 25
The number of volunteers with adverse events as a measure of safety and tolerability
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: up to Day 25