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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
16
pyrotinib maleate administration in fasted condition in period 1, pyrotinib maleate administration after low-fat diet in period 2
pyrotinib maleate administration after low-fat diet in period 1, pyrotinib maleate administration in fasted condition in period 2
Pharmacokinetics parameter: Cmax of pyrotinib
Peak Plasma Concentration (Cmax) of pyrotinib
Time frame: through study completion, an average of 28 days
Pharmacokinetics parameter: AUC of pyrotinib
Area under the plasma concentration versus time curve (AUC) of pyrotinib
Time frame: through study completion, an average of 28 days
Pharmacokinetics parameter: Tmax of pyrotinib
Time of maximum observed concentration (Tmax) of pyrotinib
Time frame: through study completion, an average of 28 days
Pharmacokinetics parameter: T1/2 of pyrotinib
Half time (T1/2) of pyrotinib
Time frame: through study completion, an average of 28 days
Pharmacokinetics parameter: CL/F of pyrotinib
Total body clearance for extravascular administration (CL/F) of pyrotinib
Time frame: through study completion, an average of 28 days
Pharmacokinetics parameter: Vz/F of pyrotinib
Volume of distribution (Vz/F) of pyrotinib
Time frame: through study completion, an average of 28 days
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
An adverse event is any untoward medical occurrence in a patient or clinical study participant
Time frame: through study completion, an average of 28 days
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