Type 2 Diabetes
Conditions
Keywords
SP2086, Metabolite identification, Material balance
Brief summary
The purpose of the study is to investigate the Metabolite identification and material balance of SP2086 in healthy adult volunteers.
Detailed description
All subjects were given SP2086 100mg only one time, and blood sample should be collected before and 96 hours after medicine taken.
Interventions
DRUGSP2086
SP2086 was taken only one time at 100mg dose in health volunteers
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy volunteers with a body mass index(BMI) between 19 and 25 Kg/m2,and weight ≥50kg. * Lab and other examination results were normal or mildly abnormal without clinical significance, clinical doctors had considered eligible. * Had signed the informed consent himself or herself voluntarily.
Exclusion criteria
* Has a history of severe system disease, or family history (including the cardiovascular system, digestive system, urinary system, etc.). * Has a history of allergy or intolerance to SP2086 OR other DPP-IV. * The subjects participated 3 times or more than 3 times drug clinical subjects in nearly a year;participate any drug clinical trial prior to the test 3 months, or had blood donor, or plan to blood donors three months before the test;or had a transfusion in 4 weeks. * Did not take effective contraceptive measures or planning of the subjects in half a year. * Researchers considered the patient adherence is poor, or has any unfavorable factors that not suit to participate the test.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The maximum plasma concentration (Cmax) of SP2086 | up to 96 hours | Cmax (a measure of the body's exposure to SP2086) will be compared before and after administration of multiple doses of SP2086 |
| The maximum plasma concentration (Cmax) of SP2086 acid | up to 96 hours | Cmax (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of multiple doses of SP2086 |
| The area under the plasma concentration-time curve (AUC) of SP2086 | up to 96 hours | AUC (a measure of the body's exposure to SP2086) will be compared before and after administration of multiple doses of SP2086 |
| The area under the plasma concentration-time curve (AUC) of SP2086 acid | up to 96 hours | AUC (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of multiple doses of SP2086 |
Secondary
| Measure | Time frame |
|---|---|
| The number of volunteers with adverse events as a measure of safety and tolerability | up to 96 hours |
Outcome results
None listed