drugset / Trial / NCT04850651

Effect of Fluconazole on the Pharmacokinetics of Pyrotinib in Healthy Subjects

NCT04850651

Phase 1 Completed 18 enrolled Jiangsu HengRui Medicine Co., Ltd.
NaSingle-groupOpen-labelOther

Summary

The primary objective of the study is to evaluate the effect of fluconazole on pharmacokinetics of pyrotinib tablet for oral administration in healthy Chinese adult subjects. The secondary objective of the study is to compare the safety of pyrotinib alone and co-administered with fluconazole.

Timeline

Start
2021-04-16
Primary completion
2021-05-17
Completion
2021-05-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Fluconazole Small molecule 200 mg Oral
Subject Pyrotinib Small molecule 80 mg Oral

Indications

No indication recorded.