SP2086 is a novel inhibitor of Dipeptide base peptidase 4, allows an insulin-independent approach to improve type 2 diabetes hyperglycemia. In this single-dose and multiple-dose study the investigators evaluated the safety, tolerability and Pharmacokinetics profiles of SP2086 in healthy volunteers.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
The study has 3 doses groups and the 30 subjects were administrated SP2086 50mg,100mg,200mg respectively.
the First Hosital of Jilin University
Changchun, Jilin, 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 a single dose of SP2086.
Time frame: up to Day 13
The steady-state plasma concentration (Css) of SP2086
Css (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 13
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 a single dose of SP2086.
Time frame: up to Day 13
The steady-state plasma concentration (Css) of SP2086 acid
Css (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 13
The maximum urine concentration (Cmax) of SP2086
Cmax (a measure of the body's exposure to SP2086) will be compared before and after administration of a single dose of SP2086
Time frame: up to Day 13
The steady-state urine concentration (Css) of SP2086
Css (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 13
The maximum urine concentration (Cmax) of SP2086 acid
Cmax (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of a single dose of SP2086
Time frame: up to Day 13
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The steady-state urine concentration (Css) of SP2086 acid
Css (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 13
Cumulative excretion of SP2086
Time frame: up to Day 13
The number of volunteers with adverse events as a measure of safety and tolerability
Time frame: up to Day 13