This study will be a randomized 3-treatment, cross-over study to evaluate the bioavailability of XZP-3287 administered after a high or low-fat meal.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Cycle1 Day 1: one dose of XZP-3287 before starting a low-fat breakfast Cycle2 Day 1: one dose of XZP-3287 after finishing a high-fat breakfast Cycle3 Day 1: one dose of XZP-3287 after finishing a low-fat breakfast
Cycle1 Day 1: one dose of XZP-3287 after finishing a high-fat breakfast Cycle2 Day 1: one dose of XZP-3287 after finishing a low-fat breakfast Cycle3 Day 1: one dose of XZP-3287 before starting a low-fat breakfast
Cycle1 Day 1: one dose of XZP-3287 after finishing a low-fat breakfast Cycle2 Day 1: one dose of XZP-3287 before starting a low-fat breakfast Cycle3 Day 1: one dose of XZP-3287 after finishing a high-fat breakfast
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
RECRUITINGPrimary PK Endpoints
Cmax
Time frame: day 1~day 21
Primary PK Endpoints
AUC0-∞
Time frame: day 1~day 21
Primary PK Endpoints
AUC0-t
Time frame: day 1~day 21
Secondary PK measures
Tmax
Time frame: day 1~day 21
Secondary PK measures
T1/2
Time frame: day 1~day 21
Secondary PK measures
CL/F
Time frame: day 1~day 21
Secondary PK measures
Vz/F
Time frame: day 1~day 21
Safety and tolerability
Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE 5.0
Time frame: Up to 14 days after last dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Cycle1 Day 1: one dose of XZP-3287 before starting a low-fat breakfast Cycle2 Day 1: one dose of XZP-3287 after finishing a low-fat breakfast Cycle3 Day 1: one dose of XZP-3287 after finishing a high-fat breakfast
Cycle1 Day 1: one dose of XZP-3287 after finishing a high-fat breakfast Cycle2 Day 1: one dose of XZP-3287 before starting a low-fat breakfast Cycle3 Day 1: one dose of XZP-3287 after finishing a low-fat breakfast
Cycle1 Day 1: one dose of XZP-3287 after finishing a low-fat breakfast Cycle2 Day 1: one dose of XZP-3287 after finishing a high-fat breakfast Cycle3 Day 1: one dose of XZP-3287 before starting a low-fat breakfast