Effect of a High-fat Meal on the Pharmacokinetics of SHR3824 and Mass Balance Study in Healthy Subjects
- Registration Number
- NCT02353975
- Lead Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 12
Inclusion Criteria
- Healthy.
- BMI 18-25 kg/m2.
Exclusion Criteria
- History of clinically significant illness.
- History of alcohol or drug abuse.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description SHR3824 10mg fed to fasted SHR3824 SHR3824, high fat, high calorie breakfast day 1, visit 2, 7 days wash-out, SHR3824, fasting conditions day 1, visit 3. SHR3824 10mg fasted to fed SHR3824 SHR3824 tablet, fasting conditions day 1, visit 2, 7 days wash-out, SHR3824 tablet, high fat, high calorie breakfast day 1, visit 3.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method The number of volunteers with adverse events as a measure of safety and tolerability. Up to Day 12