Type 2 Diabetes
Conditions
Brief summary
This is an open single and self-control study,planning to recruit 24 cases of healthy male volunteers.In the study,subjects were given SP2086 and metformin,and collects blood samples before and after medcine.The purpose is to evaluate the drug interaction between SP2086 and Metformin.
Interventions
DRUGSP2086
DRUGMetformin
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, a measure of a person's weight in relation to height) between 19 and 26 kg/m2,weight among of 50-100kg. * willing to using contraception during the study and after the 6 months.
Exclusion criteria
* History of diabetes * History of heart failure or renal insufficiency * Urinary tract infections, or vulvovaginal mycotic infections * History of or current clinically significant medical illness as determined by the Investigator * History of clinically significant allergies, especially known hypersensitivity or intolerance to lactose * Known allergy to SP2086 or metformin or any of the excipients of the formulation of SP2086 or metformin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The maximum plasma concentration (Cmax) of SP2086 acid | up to Day 9 | Cmax (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of a single dose of metformin |
| The maximum plasma concentration (Cmax) of SP2086 | up to Day 9 | Cmax (a measure of the body's exposure to SP2086) will be compared before and after administration of a single dose of metformin |
| The area under the plasma concentration-time curve (AUC) of SP2086 | up to Day 9 | AUC (a measure of the body's exposure to SP2086) will be compared before and after administration of a single dose of metformin |
| The area under the plasma concentration-time curve (AUC) of metformin | up to Day 9 | AUC (a measure of the body's exposure to metformin) 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 Day 9 | AUC (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of a single dose of metformin |
| The maximum plasma concentration (Cmax) of Metformin | up to Day 9 | Cmax (a measure of the body's exposure to metformin) 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 Day 9 |
Outcome results
None listed