drugset / Trial / NCT04315116

A Drug-drug Interaction Trial of Loperamide Pharmacokinetics Effect on Pyrotinib Maleate

NCT04315116

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

Summary

The primary objective of the study was to assess the effect of repeated oral doses of Loperamide on the pharmacokinetic profile of a single dose of Pyrotinib Maleate. The secondary objective of the study was to assess the safety of Pyrotinib Maleate given alone versus Fluzoparib coadministered with Loperamide.

Timeline

Start
2020-04-13
Primary completion
2020-04-30
Completion
2020-09-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Loperamide Small molecule 4 mg Oral
Subject Pyrotinib Small molecule Oral

Indications

No indication recorded.