Type 2 Diabetes
Conditions
Brief summary
The purpose of the study is to investigate the potential interaction between multiple oral doses of SP2086 and a single oral dose of Simvastatin in healthy adult volunteers.
Detailed description
This is an open-label (volunteers will know the names of treatments they are assigned) single-center study of SP2086 and Simvastatin in healthy adult volunteers. SP2086 will be administered orally (by mouth) as 100 mg on Days 4, 5, 6, 7, and 8 and Simvastatin will be administered orally as two 20mg tablets on Days 1 and 8. Both SP2086 and Simvastatin tablets will be taken with 8 ounces (240 mL) of water.
Interventions
DRUGSP2086
SP2086 will be administered orally (by mouth) as 100 mg on Days 4, 5, 6, 7, and 8 and Simvastatin will be administered orally as two 20mg tablets on Days 1 and 8. Both SP2086 and Simvastatin tablets will be taken with 8 ounces (240 mL) of water.
DRUGSimvastatin
SP2086 will be administered orally (by mouth) as 100 mg on Days 4, 5, 6, 7, and 8 and Simvastatin will be administered orally as two 20mg tablets on Days 1 and 8. Both SP2086 and Simvastatin tablets will be taken with 8 ounces (240 mL) of water.
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
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 Simvastatin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The maximum plasma concentration (Cmax) of Simvastatin | up to Day 9 | Cmax (a measure of the body's exposure to Simvastatin) will be compared. before and after administration of multiple doses of SP2086 |
| 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 Simvastatin. |
| 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 Simvastatin. |
| The area under the plasma concentration-time curve (AUC) of Simvastatin | up to Day 9 | AUC (a measure of the body's exposure to Simvastatin) 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 Day 9 | AUC (a measure of the body's exposure to SP2086) will be compared before and after administration of a single dose of Simvastatin. |
| 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 Simvastatin. |
Secondary
| Measure | Time frame |
|---|---|
| The number of volunteers with adverse events as a measure of safety and tolerability | up to Day 9 |
Countries
China
Outcome results
None listed