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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 20 mg single dose cohort | Experimental | Subjects would receive a 20 mg single dose of EXPAREL® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine liposome injectable suspension | Drug | Single dose of Bupivacaine liposome injectable suspension 266 mg in 20 mL |
|
| Measure | Description | Time Frame |
|---|---|---|
| plasma concentration | Maximum observed plasma concentration (Cmax) | 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-∞) | up to 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bernard Cheung, Doctor | Queen Mary Hospital, Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HUK Phase 1 clinical trials center | Hong Kong | Hongkong | 999077 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34315419 | Derived | Cheung BM, Ng PY, Liu Y, Zhou M, Yu V, Yang J, Wang NQ. Pharmacokinetics and safety of liposomal bupivacaine after local infiltration in healthy Chinese adults: a phase 1 study. BMC Anesthesiol. 2021 Jul 27;21(1):197. doi: 10.1186/s12871-021-01407-5. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 12, 2020 | |
| Reset | Jul 22, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 12, 2020 | Jul 22, 2020 |
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| up to 21 days |