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To evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of propofol injectable emulsion, and to assess the bioequivalence of test and reference formulations in healthy Chinese adult volunteers.
Thirty-two healthy Chinese adult volunteers were recruited and randomly assigned to a fasting. single-dose, two-period and double-crossover study. Propofol was given to eligible subjects at a speed of 30 μg·kg-1·min-1 for 30 min. The concentration of propofol in plasma was determined by avalidated high performance liquid chromatography-tandem mass spectrometery (HPLC-MS/MS) method. The PK parameters of the two preparations were calculated. Bispectral index (BIS) was measured to calculate the PD parameters of two formulations. Adverse events during the trial were recorded.
Thirty-one volunteers were included in the pharmacokinetic parameter set. The mean values of PK parameters of test andreference formulations were as follows: Cmax were (660.87±110.25) and (683.13±125.75)ng·mL-1; AUC0-t were (473.50±86.03) and (478.40±80.25)h·ng·mL-1; AUC0-∞ were (500.45±96.49) and (507.84±88.00)h·ng·mL-1; tmax were 0.47(0.25,0.53) and 0.50(0.40, 0.54)h; t1/2 were (2.97±1.74) and (3.08±1.82)h. Thirty-one volunteers were included in the bioequivalence set. The 90% confidence intervals (CI) for the geometric mean ratios of Cmax, AUC0-t, AUC0-∞ were 92.64%-101.39%, 96.43%-101.00%, 95.67%-100.70%, respectively. The mean values of PD parameters of test and reference formulations were as follows: BISmin were (75.94±13.66) and (74.39±12.32); BISAUC 0-60 min were 5 569.85±182.78 and 5 575.68±166.19; T-BISmin were 23.00 and 29.00 min, respectively. There were no serious adverse events.
Two formulations of propofol injectable emulsion were bioequivalent and both of them exhibited good safety.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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