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Effect of Itraconazole on the Pharmacokinetics of SHR6390 in Healthy Subjects

Healthy Subjects Clinical Trial

Official title:
A Single-centre, Open, Single-dose, Self-control Study to Investigate the Effect of Itraconazole on the Pharmacokinetics of SHR6390 in Healthy Chinese Adult Subjects.

Clinical Trial 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 SHR6390 tablets. The secondary objective of the study is to evaluate the safety of SHR6390 alone and when co-administered with itraconazole. The exploratory objective of the study is to explore the effect of SHR6390 related metabolic enzymes and transporter gene polymorphisms on the pharmacokinetics of SHR6390.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04423601
Study type Interventional
Source Jiangsu HengRui Medicine Co., Ltd.
Contact
Status Completed
Phase Phase 1
Start date June 10, 2020
Completion date February 2, 2021
View Details
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