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This study assessed the bioequivalence and safety of a single dose of Propofol Medium/Long Chain Fat Emulsion Injection (Test product, Haisco Pharmaceutical Group Co., Ltd.) compared to the reference product (Propofol Medium/Long Chain Fat Emulsion Injection, Fresenius Kabi Deutschland GmbH) in healthy Chinese subjects. Additionally, the pharmacodynamic profiles of both formulations were evaluated
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test formulation | Experimental | Propofol Medium and Long Chain Fat Emulsion Injection (20 mL:0.2g) Manufacturer: Haisco Pharmaceutical Group Co., Ltd |
|
| Reference formulation | Experimental | Propofol Medium and Long Chain Fat Emulsion Injection (20 mL:0.2g) Manufacturer: Fresenius Kabi Deutschland GmbH |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tested Propofol Medium and Long Chain Fat Emulsion Injection (T) | Drug | Single-dose intravenous infusion of the test formulation under fasting conditions at 30 μg/kg/min. Infusion time: 30 minutes. Dosage: 900 μg/kg for both administrations |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | The maximum blood concentration, the pharmacokinetic parameters of Propofol in plasma | From the start of intravenous infusion to 480 minutes after the intravenous infusion |
| AUC(0-t) | The area under the blood concentration-time curve from time 0 to the last accurately measurable concentration at sample collection time t was measured, the pharmacokinetic parameters of Propofol in plasma | From the start of intravenous infusion to 480 minutes after the intravenous infusion |
| AUC(0-∞) | The area under the blood concentration-time curve from 0 to infinite time (∞), the pharmacokinetic parameters of Propofol in plasma | From the start of intravenous infusion to 480 minutes after the intravenous infusion |
| Measure | Description | Time Frame |
|---|---|---|
| BIS AUC0-60min | Area under the BIS positive peak-time curve from 0 to 60 minutes after converting the BIS value to a positive peak (100-BIS) | From the start of intravenous infusion to 60 minutes after the intravenous infusion |
| BISmin |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | China |
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| Reference Propofol Medium and Long Chain Fat Emulsion Injection (R) | Drug | Single-dose intravenous infusion of the reference formulation under fasting conditions at 30 μg/kg/min. Infusion time: 30 minutes. Dosage: 900 μg/kg for both administrations |
|
Minimum BIS value
| From the start of intravenous infusion to 60 minutes after the intravenous infusion |
| t-BISmin | Time to reach the minimum BIS value | From the start of intravenous infusion to 60 minutes after the intravenous infusion |
| AEs | The incidence and severity of AEs | From the time of signing ICF to the end of follow-up,up to 10 days |