Overview
Effect of a High-fat Meal on the Pharmacokinetics of SHR0302 and Mass Balance Study in Healthy Subjects
Status:
Unknown status
Unknown status
Trial end date:
2016-10-01
2016-10-01
Target enrollment:
0
0
Participant gender:
Male
Male
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.Phase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Criteria
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.