NCT05392127

A Pharmacokinetic Study to Evaluate the Drug Interaction Between SHR0302 and CYP Substrates in Healthy Volunteers

A Single-center, Open-label, Single-arm, Fixed-sequence Study to Evaluate the Pharmacokinetic Effects of SHR0302 Tablets on Substrates of CYP3A4, CYP2C8, CYP2C9, CYP2C19 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a drug-drug interaction study conducted in healthy volunteers to evaluate the pharmacokinetic effect of SHR0302 on CYP3A4, CYP2C9, CYP2C9, CYP2C19, using midazolam, s-warfarin, omeprazole, and repaglinide as probe drugs.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	SHR0302 Tablets	SHR0302 Tablets once daily
DRUG	Midazolam Maleate Tablets	Midazolam Maleate Tablets single dose
DRUG	Warfarin Sodium Tablets	Warfarin Sodium Tablets single dose
DRUG	Omeprazole Enteric Capsules	Omeprazole Enteric Capsules single dose
DRUG	Vitamin K1 Tablets	Vitamin K1 Tablets once daily
DRUG	Repaglinide Tablets	Repaglinide Tablets single dose

Timeline

• Start date: 2022-07-15
• Primary completion: 2022-08-18
• Completion: 2022-08-18
• First posted: 2022-05-26
• Last updated: 2022-12-22

Locations

1 site across 1 country: China