NCT04291846

A Food Effect Study of SHR1459 on Healthy Chinese Adult Subjects

A Randomized, Open, Single-center, Two-cycle, Double-sequence Crossover Study to Investigate the Effects of a High-fat Diet on the Pharmacokinetics of Healthy Chinese Adult Subjects After Oral Administration of SHR1459 Tablets

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The primary objective of the study is to evaluate the effect of high-fat diet on pharmacokinetics of healthy Chinese adult subjects after oral administration of SHR1459 tablets. The secondary objective of the study is to evaluate the safety of single dose of SHR1459 orally in healthy subjects.

Conditions

• Healthy Adult Subjects

Interventions

Type	Name	Description
DRUG	SHR1459 fasted in P1, high-fat diet in P2	SHR1459 administration in fasted condition in period 1, SHR1459 administration after high-fat diet in period 2
DRUG	SHR1459 high-fat diet in P1, fasted in P2	SHR1459 administration after high-fat diet in period 1, SHR1459 administration in fasted condition in period 2

Timeline

• Start date: 2020-05-24
• Primary completion: 2020-06-03
• Completion: 2020-06-29
• First posted: 2020-03-02
• Last updated: 2020-07-27

Locations

1 site across 1 country: China