NCT02892370

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (estimated)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	SHR0302	SHR0302 tablets (10 mg)

Timeline

• Start date: 2016-08-01
• Primary completion: 2016-09-01
• Completion: 2016-10-01
• First posted: 2016-09-08
• Last updated: 2016-09-08

Locations

1 site across 1 country: China