Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study aims to investigate the pharmacokinetics of bupivacaine liposomal injection (test preparation) in healthy subjects. The manufactured liposomal bupivacaine injection (EXPAREL®) was used as the reference formulation to evaluate the human bioequivalence between the two formulations.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupivacaine liposome injection T preparation group | Experimental |
| |
| Bupivacaine liposome injection R preparation group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine Liposome Injection T preparation | Drug | Bupivacaine Liposome Injection T preparation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax). | Blood samples will be collected. | From 0 hour predose up to 240 hours postdose. |
| Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUC0-t). | Blood samples will be collected. | From 0 hour predose up to 240 hours postdose. |
| Area under the plasma concentration-time curve from time 0 to infinity (AUC0-∞). | Blood samples will be collected. | From 0 hour predose up to 240 hours postdose. |
| Measure | Description | Time Frame |
|---|---|---|
| Observed time to reach Cmax (Tmax). | Blood samples will be collected. | From 0 hour predose up to 240 hours postdose. |
| Adverse events (AEs). | From 0 hour predose up to 35 days postdose. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jilin University First Hospital | Changchun | Jilin | 130000 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Bupivacaine Liposome Injection R preparation | Drug | Bupivacaine Liposome Injection R preparation |
|
|