/ Not yet recruitingNot Applicable 达格列净片（10mg）在中国健康受试者中空腹和餐后给药条件下随机、开放、单剂量、两序列、两周期、双交叉生物等效性试验
[Translation] A randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence study of dapagliflozin tablets (10 mg) in healthy Chinese subjects under fasting and fed conditions
主要研究目的：按有关生物等效性试验的规定，选择AstraZeneca AB为持证商的达格列净片（商品名：安达唐®（FORXIGA®），规格：10mg）为参比制剂，对重庆博腾药业有限公司生产并提供的受试制剂达格列净片（规格：10mg）进行空腹和餐后给药条件下的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：观察健康受试者口服受试制剂达格列净片（规格：10mg）和参比制剂达格列净片（商品名：安达唐®（FORXIGA®），规格：10mg）的安全性。
[Translation] Main purpose of study: According to the provisions of relevant bioequivalence test, dapagliflozin tablets (trade name: FORXIGA®, specification: 10 mg) with AstraZeneca AB as the licensee were selected as the reference preparation, and the test preparation dapagliflozin tablets (specification: 10 mg) produced and provided by Chongqing Boteng Pharmaceutical Co., Ltd. were subjected to human bioequivalence test under fasting and postprandial administration conditions, 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 and postprandial administration conditions.
Secondary purpose of study: To observe the safety of oral administration of the test preparation dapagliflozin tablets (specification: 10 mg) and the reference preparation dapagliflozin tablets (trade name: FORXIGA®, specification: 10 mg) by healthy subjects.
/ Not yet recruitingNot Applicable 阿帕他胺片（60mg）在中国健康受试者中空腹和餐后给药条件下随机、开放、单剂量、两序列、两周期、双交叉生物等效性试验
[Translation] A randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence study of apalutamide tablets (60 mg) in Chinese healthy subjects under fasting and fed conditions
主要研究目的：按有关生物等效性试验的规定，选择Janssen-Cilag International NV持证的阿帕他胺片（商品名：Erleada（安森珂）；规格：60mg）为参比制剂，对重庆博腾药业有限公司生产并提供的受试制剂阿帕他胺片（规格：60mg）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：观察健康受试者口服受试制剂阿帕他胺片（规格：60mg）和参比制剂阿帕他胺片（商品名：Erleada（安森珂）；规格：60mg）的安全性。
[Translation] Main study purpose: According to the relevant provisions of bioequivalence test, apalutamide tablets (trade name: Erleada; specification: 60mg) certified by Janssen-Cilag International NV were selected as the reference preparation, and the test preparation apalutamide tablets (specification: 60mg) produced and provided by Chongqing Boteng Pharmaceutical Co., Ltd. were subjected to human bioequivalence test on fasting and postprandial administration, 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 and postprandial administration conditions.
Secondary study purpose: To observe the safety of oral administration of the test preparation apalutamide tablets (specification: 60mg) and the reference preparation apalutamide tablets (trade name: Erleada; specification: 60mg) in healthy subjects.
/ CompletedNot Applicable 硫酸羟氯喹片在中国健康受试者空腹/餐后状态下， 单中心、 随机、 开放、 两制剂、 单剂量、 单周期、 平行设计的生物等效性试验
[Translation] A single-center, randomized, open-label, two-formulation, single-dose, single-period, parallel-design bioequivalence trial of hydroxychloroquine sulfate tablets in Chinese healthy subjects under fasting/fed conditions
本试验为生物等效性试验，以Sanofi-Aventis持证的硫酸羟氯喹片（商品名：PLAQUENIL®，规格：0.2g）为参比制剂，以重庆博腾药业有限公司生产的硫酸羟氯喹片（规格：0.2g）为受试制剂，通过单中心、随机、开放、两制剂、单剂量、单周期、平行设计试验，评价两种制剂在空腹及餐后给药条件下的生物等效性。
[Translation] This is a bioequivalence trial, with Sanofi-Aventis certified hydroxychloroquine sulfate tablets (trade name: PLAQUENIL®, specification: 0.2g) as the reference preparation, and hydroxychloroquine sulfate tablets (specification: 0.2g) produced by Chongqing Boteng Pharmaceutical Co., Ltd. as the test preparation. A single-center, randomized, open, two-preparation, single-dose, single-period, parallel design trial was used to evaluate the bioequivalence of the two preparations under fasting and postprandial administration conditions.
100 Clinical Results associated with Chongqing Boteng Pharmaceutical Technology Co., Ltd.
0 Patents (Medical) associated with Chongqing Boteng Pharmaceutical Technology Co., Ltd.
100 Deals associated with Chongqing Boteng Pharmaceutical Technology Co., Ltd.
100 Translational Medicine associated with Chongqing Boteng Pharmaceutical Technology Co., Ltd.
