NCT04586803

Study on the Bioavailability of Three Different Prescription Processes of SHR4640 Tablets in Healthy Volunteers

Study on the Bioavailability of Three Different Prescription Processes of SHR4640 Tablets in Healthy Volunteers (Single Center, Randomized, Open, 3 Cycles, 6 Sequences)

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (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 relative bioavailability of three different prescription processes 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

Study Type: Interventional Enrollment: Number of Subjects: 24 Type: Anticipated Allocation : Yes Intervention Model : Single center, randomized, open Intervention Model Description: 3 cycles, 6 sequences Masking: No Masking Subjects were randomly divided into the group A, B, C, D, E and F. On D1, D8 and D15, six groups of subjects were respectively given A version or C version or D version of SHR4640 tablet.

Conditions

• Primary Gout
• Hyperuricemia

Interventions

Type	Name	Description
DRUG	SHR4640	Subjects were randomly divided into the group A, B, C, D, E and F. On D1, D8 and D15, six groups of subjects were respectively given A version or C version or D version of SHR4640 tablet.

Timeline

• Start date: 2020-10-01
• Primary completion: 2020-11-01
• Completion: 2020-12-01
• First posted: 2020-10-14
• Last updated: 2020-10-14