Type 2 Diabetes
Conditions
Keywords
SHR3824 SP2086 drug-drug interaction
Brief summary
The purpose of the study is to investigate the potential interaction between multiple oral doses of SHR3824 and multiple oral doses of SP2086 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 SHR3824 and SP2086 in healthy adult volunteers. SHR3824(a Sodium-Glucose Cotransporter 2 inhibitor) is currently under development to lower blood sugar levels in patients with type 2 diabetes mellitus (T2DM) ,and SP2086(a Dipeptidyl peptidase IV inhibitor) is also currently under development to lower blood sugar levels in patients with type 2 diabetes mellitus (T2DM).SP2086 will be administered orally (by mouth) as 100mg on Days 1, 2, 3, 4, 15, 16, 17 and 18, SHR3824 will be administered orally (by mouth) as 20mg on Days 11, 12, 13, 14, 15, 16, 17 and 18. Both SHR3824 and SP2086 tablets will be taken with 8 ounces (240 mL) of water.
Interventions
DRUGSHR3824, SP2086
One 100-mg tablet of SP2086 once daily on Day 1,2,3,4 followed by two 10-mg tablets of SHR3824 once daily on Day 11,12,13,14, followed by one 100-mg tablet of SP2086 and two 10-mg tablets of SHR3824 on Day 15,16,17,18.
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 24 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 SHR3824 or SP2086 or any of the excipients of the formulation of SHR3824 or SP2086
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The maximum plasma concentration (Cmax) of SHR3824. | At protocol-specified times up to Day 14 and Day 18. | Cmax (a measure of the body's exposure to SHR3824) will be compared before and after administration of multiple doses of SP2086. |
| The area under the plasma concentration-time curve (AUC) of SHR3824. | At protocol-specified times up to Day 14 and Day 18. | AUC (a measure of the body's exposure to SHR3824) will be compared before and after administration of multiple doses of SP2086. |
| The maximum plasma concentration (Cmax) of SP2086. | At protocol-specified times up to Day 4 and Day 18. | Cmax (a measure of the body's exposure to SP2086) will be compared. before and after administration of multiple doses of SHR3824 |
| The area under the plasma concentration-time curve (AUC) of SP2086. | At protocol-specified times up to Day 4 and Day 18. | AUC (a measure of the body's exposure to SP2086) will be compared before and after administration of multiple doses of SHR3824. |
| The number of volunteers with adverse events as a measure of safety and tolerability. | Up tp day 18. | — |
Countries
China
Contacts
Primary ContactHaiyan Liu, PhD
Outcome results
None listed