NCT04315493

Effect of Low-fat Diet on the Pharmacokinetics of Pyrotinib in Healthy Participants

A Randomized, Open, Single-dose, Two-cycle, Double-sequence, Crossover Study to Investigate the Effects of a Low-fat Diet On the Pharmacokinetics of Healthy Chinese Adult Participants After Oral Administration of Pyrotinib Maleate Tablets

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (estimated)
• 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 low-fat diet on pharmacokinetics of healthy Chinese adult participants after oral administration of pyrotinib maleate tablets. The secondary objective of the study is to evaluate the safety of single dose of pyrotinib orally in healthy participants.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	pyrotinib maleate fasted in P1, low-fat diet in P2	pyrotinib maleate administration in fasted condition in period 1, pyrotinib maleate administration after low-fat diet in period 2
DRUG	pyrotinib maleate low-fat diet in P1, fasted in P2	pyrotinib maleate administration after low-fat diet in period 1, pyrotinib maleate administration in fasted condition in period 2

Timeline

• Start date: 2020-03-01
• Primary completion: 2020-03-01
• Completion: 2020-04-01
• First posted: 2020-03-19
• Last updated: 2020-03-19