NCT05404724

Study on the Pharmacokinetic Effect of Itraconazole on SHR0302 Tablets in Healthy Subjects

Study on the Pharmacokinetic Effects of Single-centered, Open, Single-arm, Fixed-sequence Itraconazole on SHR0302 Tablets in Healthy Subjects

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

Summary

To evaluate the effect of oral itraconazole on the pharmacokinetics of SHR0302 in healthy subjects. To evaluate the safety and tolerability of oral SHR0302 and itraconazole monotherapy and combination use in healthy subjects.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	itraconazole、 SHR0302 tablets	Itraconazole 7 times and SHR0302 tablets twice. On the 8th day of this, itraconazole and SHR0302 tablets were taken simultaneously.

Timeline

• Start date: 2022-06-25
• Primary completion: 2022-07-11
• Completion: 2022-07-11
• First posted: 2022-06-03
• Last updated: 2022-12-22

Locations

1 site across 1 country: China