This is a single-center, open-label, single-dose study to evaluate the safety, pharmacokinetics in healthy subjects
This is a phase I, open-label, single-dose in healthy subjects conducted at single center.The objectives are to evaluate the metabolic and safety profile of EXPAREL®. Each volunteer will receive one dose of the investigational drug via subcutaneous injection at multiple points during the study period. Study duration is around 54 days, including screening, confinement, ambulatory visit and a phone follow up.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
20
Single dose of Bupivacaine liposome injectable suspension 266 mg in 20 mL
HUK Phase 1 clinical trials center
Hong Kong, Hongkong, China
plasma concentration
Maximum observed plasma concentration (Cmax)
Time frame: up to 14 days
Area under the plasma concentration-versus-time curve
Area under the plasma concentration-versus-time curve from time 0 extrapolated to infinity after drug administration (AUC0-∞)
Time frame: up to 14 days
Incidence of adverse events(AEs)which are related to exparel injection
Adverse events refer to any treatment related abnormality with clinical significance identified by means of vital signs examination, physical check-up, twelve leads electrocardiogram inspection and laboratory tests throughout the study. Adverse events reported by subjects would also be recorded in the entire trial. All these abnormal cases described above would be reported as incidence of adverse events.
Time frame: up to 21 days
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