Efavirenz/Lamivudine/Tenofovir Disoproxil Fumarate

Main research purpose: According to the relevant provisions of bioequivalence test, the certified efamivir tablets (I) (trade name: SYMFI LO®, specification: each tablet contains 0.4g efavirenz, 0.3g lamivudine and 0.3g tenofovir disoproxil fumarate) of Mylan Pharmaceuticals Inc were selected as the reference preparation, and the test preparation efamivir tablets (I) (specification: each tablet contains 0.4g efavirenz, 0.3g lamivudine and 0.3g tenofovir disoproxil fumarate) produced by Anhui Baker Biopharmaceutical Co., Ltd. were subjected to fasting human bioequivalence test to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under fasting conditions. Secondary study objective: To observe the safety of oral administration of the test preparation efamivir tablets (I) (specification: each tablet contains 0.4g efavirenz, 0.3g lamivudine and 0.3g tenofovir disoproxil fumarate) and the reference preparation efamivir tablets (I) (trade name: SYMFI LO®, specification: each tablet contains 0.4g efavirenz, 0.3g lamivudine and 0.3g tenofovir disoproxil fumarate) in healthy subjects.

Main research objectives: To study the pharmacokinetic parameters and relative bioavailability of single-dose efavirenz, lamivudine and tenofovir tablets (specifications: 0.4g/0.3g/0.3g) developed by Shanghai Desano Biopharmaceutical Co., Ltd. and the reference preparation SYMFI LOTM (specifications: 400mg/300mg/300mg) produced by Mylan Laboratories Limited under fasting state, and to evaluate whether the two are bioequivalent. Secondary research objectives: To investigate the safety of the test preparation efavirenz, lamivudine and tenofovir tablets and the reference preparation SYMFI LOTM in healthy subjects.