This study is divided into Part I and Part II. Part I is the food effect study. A total of 20 healthy subjects, regardless of gender, will be enrolled in a randomized, open-label, crossover design. Part II is the drug-drug interaction study, an open-label and sequential design. 32 healthy subjects are planned to be enrolled and divided into group A and group B. Group A is to evaluate the influence of itraconazole as CYP3A4 strong inhibitory on HLX208. Group B was to evaluate the effect of rifampicin as a strong inducer of CYP3A4 on HLX208.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Subjects will receive treatment HLX208 900 mg in the fast state followed by 7 days washout ,then receive treatment HLX208 900 mg in the fed state
Subjects will receive treatment HLX208 900 mg in the fed state followed by 7 days washout ,then receive treatment HLX208 900 mg in the fast state.
450 mg
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Pharmacokinetics parameter Cmax of HLX208
Cmax of HLX208
Time frame: up to 48 hours
Pharmacokinetics parameter AUC0-t of HLX208
AUC0-t of HLX208
Time frame: up to 48 hours
Pharmacokinetics parameter AUC0-inf of HLX208
AUC0-inf of HLX208
Time frame: up to 48 hours
other pharmacokinetics parameter Tmax of HLX208
Tmax of HLX208
Time frame: up to 48 hours
other pharmacokinetics parameter Tlag of HLX208
Tlag of HLX208
Time frame: up to 48 hours
other pharmacokinetics parameter t1/2 of HLX208
t1/2 of HLX208
Time frame: up to 48 hours
other pharmacokinetics parameter CL/F of HLX208
CL/F of HLX208
Time frame: up to 48 hours
other pharmacokinetics parameter Vd/F of HLX208
Vd/F of HLX208
Time frame: up to 48 hours
other pharmacokinetics parameter MRT of HLX208
MRT of HLX208
Time frame: up to 48 hours
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900 mg
200 mg
600mg
other pharmacokinetics parameter %AUCex of HLX208
%AUCex of HLX208
Time frame: up to 48 hours
The incidence and severity of adverse events/serious adverse events
Occurrence of Serious Adverse Event (SAE), Adverse Event (AE)
Time frame: up to 17 days after the last dose