Type 2 Diabetes
Conditions
Keywords
SHR3824, food effect, mass, balance, Phase I
Brief summary
This open-label, randomized, two-period, two-treatment (single doses of 10 mg SHR3824 fasted or fed), crossover study was conducted to evaluate the effect of a high-fat meal on the pharmacokinetics of SHR3824 and mass balance study in 12 healthy subjects.
Interventions
DRUGSHR3824
SHR3824 tablet,10mg, fasting conditions and high fat, high calorie breakfast.
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy. * BMI 18-25 kg/m2.
Exclusion criteria
* History of clinically significant illness. * History of alcohol or drug abuse.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The maximum plasma concentration (Cmax) of SHR3824 | Day 1-4 on visit 2 and visit 3 | Cmax (a measure of the body's exposure to SHR3824) will be compared under fating state and fasted state |
| The area under the plasma concentration-time curve (AUC) of SHR3824 | Day 1-4 on visit 2 and visit 3 | AUC (a measure of the body's exposure to SHR3824) will be compared under fating state and fasted state |
| The accumulative excretion rate of SHR3824 and its metabolites in urine and feces | Day 1-4 on visit 2 and visit 3 | Accumulative excretion rate will be compared under fating state and fasted state |
Secondary
| Measure | Time frame |
|---|---|
| The number of volunteers with adverse events as a measure of safety and tolerability. | Up to Day 12 |
Outcome results
None listed