Type 2 Diabetes
Conditions
Brief summary
The purpose of the study is to investigate the potential PK interaction between SP2086 and Valsartan after multiple oral doses treatment in healthy male volunteers.
Interventions
DRUGSP2086
SP2086 will be administered orally (by mouth) as 100mg on Days 4, 5, 6, 7, and 8 and Valsartan will be administered orally as two 80mg tablets on Days 1 and 8. Both SP2086 and Valsartan tablets will be taken with 8 ounces (240 mL) of water.
DRUGValsartan
SP2086 will be administered orally (by mouth) as100mg on Days 4, 5, 6, 7, and 8 and Valsartan will be administered orally as two 80mg tablets on Days 1 and 8. Both SP2086 and Valsartan 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 Valsartan or any of the excipients of the formulation of SP2086 or Valsartan
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The maximum plasma concentration (Cmax) of Valsartan | up to Day 9 | Cmax (a measure of the body's exposure to Valsartan) will be compared. before and after administration of multiple doses of SP2086 |
| 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 Valsartan |
| 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 Valsartan |
| The area under the plasma concentration-time curve (AUC) of Valsartan | up to Day 9 | AUC (a measure of the body's exposure to Valsartan) 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 Valsartan. |
| 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 Valsartan. |
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