NCT04627129

A Itraconazole Effect Study of SHR2554 on Healthy Chinese Adult Subjects

A Single-center, Open, Single Does, Drug-drug Interaction Study to Investigate the Effects of Itraconazole on the Pharmacokinetics of Healthy Chinese Adult Subjects After Oral Administration of SHR2554 Tablets

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

Summary

The primary objective of the study is to evaluate the effect of Itraconazole on pharmacokinetics of healthy Chinese adult subjects after oral administration of SHR2554 tablets. The secondary objective of the study is to evaluate the safety of single dose of SHR2554 orally in healthy subjects.

Detailed description

SHR2554 50 mg QD on Day 1 and Day 8, Itraconazole 200 mg once daily (QD) from Study Day 4 - 12

Conditions

• Healthy Adult Subjects

Interventions

Type	Name	Description
DRUG	SHR2554 and Itraconazole	Single dose of oral administration of SHR2554 and Multiple dose of oral of Itraconazole Capsules

Timeline

• Start date: 2020-06-01
• Primary completion: 2020-10-01
• Completion: 2020-10-01
• First posted: 2020-11-13
• Last updated: 2020-11-13

Locations

1 site across 1 country: China