[Translation] A randomized, open-label, single-dose, two-sequence, four-cycle, fully replicated crossover design bioequivalence study of zidoramid bivudine tablets in healthy Chinese subjects under the conditions of fasting and postprandial administration.
主要研究目的:按有关生物等效性试验的规定,选择生产商为GlaxoSmithKline的齐多拉米双夫定片(商品名:Combivir®,规格:每片含齐多夫定300mg和拉米夫定150mg)为参比制剂,对安徽贝克生物制药有限公司生产并提供的受试制剂齐多拉米双夫定片(规格:每片含齐多夫定300mg和拉米夫定150mg)进行空腹和餐后给药人体生物等效性试验,比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内,评价两种制剂在空腹和餐后给药条件下的生物等效性。
次要研究目的:观察健康志愿受试者口服受试制剂齐多拉米双夫定片(规格:每片含齐多夫定300mg和拉米夫定150mg)和参比制剂齐多拉米双夫定片(商品名:Combivir®,规格:每片含齐多夫定300mg和拉米夫定150mg)的安全性。
[Translation] Main research purpose: According to the relevant bioequivalence test regulations, select zidovudine tablets from GlaxoSmithKline (trade name: Combivir®, specifications: each tablet contains 300 mg of zidovudine and lamivudine) 150mg) is the reference preparation, and the test preparation zidovudine tablets (specification: each tablet contains zidovudine 300mg and lamivudine 150mg) produced and provided by Anhui Baker Biopharmaceutical Co., Ltd. Human bioequivalence test for postprandial administration to compare whether the difference in the absorption rate and extent of the drug in the test preparation and the reference preparation is within an acceptable range, and evaluate the two preparations under fasting and postprandial administration conditions bioequivalence.
Secondary research purpose: To observe the oral administration of the test preparation zidovudine tablets (specification: each tablet contains 300 mg of zidovudine and 150 mg of lamivudine) and the reference preparation of zidovudine in healthy volunteers Safety of fudine tablets (trade name: Combivir®, strength: each tablet contains 300 mg of zidovudine and 150 mg of lamivudine).