Effect of a High-fat Meal on the Pharmacokinetics of SHR0302 and Mass Balance Study in Healthy Subjects
- Registration Number
- NCT02892370
- Lead Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Brief Summary
The purpose of this open-label, randomized, two-period, two-treatment (single doses of 10 mg SHR0302 fasted or fed), crossover study was to evaluate the effect of a high-fat meal on the pharmacokinetics of SHR0302 and mass balance study in 14 healthy subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 14
Inclusion Criteria
- Healthy male
- BMI:19-24 kg/m2, weight > 50 kg.
- Age:18-45
Exclusion Criteria
- History of clinically significant laboratory results or disease.
- History of alcohol or drug abuse.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description SHR0302 fasted to fed SHR0302 SHR0302 tablets (10 mg) administered on day 1 fasting, and day 7 with high fat, high calorie breakfast SHR0302 fed to fasted SHR0302 SHR0302 tablets (10 mg) administered on day 1 with high fat, high calorie breakfast, and day 7 fasting
- Primary Outcome Measures
Name Time Method The maximum plasma concentration (Cmax) of SHR0302 up to 72 hrs postdose up to 72 hrs postdose on day1 and day7
The area under the plasma concentration-time curve (AUC) of SHR0302 up to 72 hrs postdose up to 72 hrs postdose on day1 and day7
The accumulative excretion rate of SHR0302 and its metabolites in urine and feces up to 96 hrs postdose up to 96 hrs postdose on day1 and day7
- Secondary Outcome Measures
Name Time Method The number of volunteers with adverse events as a measure of safety up to Day 21 required last visit via telephone during D11 to D21
Trial Locations
- Locations (1)
Shanghai Xuhui Central Hospital
🇨🇳Shanghai, Shanghai, China