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To study the bioequivalence of efavirenz, lamivudine and tenofovir disoproxil fumarate tablets (I) from two different manufacturers in healthy Chinese participants under fasting conditions.
A randomized, single-center, open-label, single-dose, two-sequence, two-period, two-way crossover design. Forty-two eligible healthy subjects were enrolled. In each period, subjects received a single oral dose of the test or reference formulation of efavirenz lamivudine tenofovir tablets (specification: each tablet contains 0.4 g efavirenz, 0.3 g lamivudine and 0.3 g tenofovir disoproxil fumarate) under fasting conditions. The plasma concentrations of efavirenz, lamivudine and tenofovir was performed using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method that had been fully validated. Pharmacokinetic parameters were calculated and the bioequivalence and safety of the two efavirenz lamivudine tenofovir tablets were evaluated.
For efavirenz, the key pharmacokinetic parametersderived from the test and reference formulations were as follows: Cmax were (1 710.25±430.44) and (1 851.26±505.57) ng·mL-1, AUC0-72 h were (37 571.38±8 747.34) and (39 391.65±8 746.77) ng·mL-1·h, tmax were [3.23±1.13 (1.00, 3.17, 5.00)] and [3.12±1.30 (1.25, 3.00, 6.03)] h, and t1/2 were (77.08±61.79) and (71.11±39.45) h, respectively. For lamivudine: Cmax were (2 397.22±689.34) and (2 388.23±618.71) ng·mL-1, AUC0-t were (12 134.48±2 526.28) and (12 324.11±2 891.50) ng·mL-1·h, tmax were [1.97±0.70 (0.67, 1.88, 4.00)] and [2.04±0.90 (0.67, 2.00, 4.51)] h, and t1/2 were (11.07±11.10) and (11.46±11.90) h, respectively. For tenofovir: Cmax were (287.40±86.07) and (304.71±91.49) ng·mL-1, AUC0-t were (2 516.91±583.47) and (2 507.40±573.45) ng·mL-1·h, tmax were [1.40±0.74 (0.50, 1.13, 3.00)] and [1.39±0.84 (0.33, 1.25, 4.00)] h, and t1/2 were (22.95±4.26) and (21.88±2.99) h, respectively. Under fasting conditions, the 90% confidence intervals of the main PK parameters of the test and reference formulations were all within 80.00% to 125.00%.
The test and reference formulations are bioequivalent under fasting conditions.
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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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