NCT04620408

Study on the Food Effects of Oral SHR4640 Tablets in Healthy Volunteers

Study on the Food Effects of Oral SHR4640 Tablets in Healthy Volunteers (Single Center, Randomized, Open, Double Crossover)

• 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 primary objective of the study is to evaluate the effect of food on the pharmacokinetics of SHR4640 tablets in healthy volunteers. The secondary objective of the study is to observe the safety of SHR4640 tablets in healthy subjects.

Detailed description

Subjects were randomly divided into the group A, B. On D1, D8, two groups of subjects were respectively given SHR4640 tablet.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	SHR4640	Subjects were randomly divided into the group A, B. On D1, D8, two groups of subjects were respectively given SHR4640 tablet.

Timeline

• Start date: 2020-12-01
• Primary completion: 2021-01-01
• Completion: 2021-02-01
• First posted: 2020-11-09
• Last updated: 2020-11-09