Effect of a High-fat Meal on the Pharmacokinetics of SHR0302 and Mass Balance Study in Healthy Subjects

An Open Label, Randomized, Two-period, Crossover Study to Assess the Effect of Food on SHR0302 and Mass Balance in Healthy Volunteers

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.

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.