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 Chinese healthy subjects under fasting and fed conditions
主要目的:以重庆康刻尔制药股份有限公司生产的达格列净片【规格:10mg】为受试制剂,按生物等效性试验的有关规定,以 AstraZeneca AB 持证的达格列净片【商品名:安达唐,规格:10mg】为参比制剂,进行空腹/餐后状态下人体生物等效性试验,评价受试制剂和参比制剂在健康受试者体内的生物等效性。
次要目的:观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Main purpose: Using dapagliflozin tablets [Specification: 10 mg] produced by Chongqing Kangkeer Pharmaceutical Co., Ltd. as the test preparation, and using dapagliflozin tablets [trade name: Andatang, specification: 10 mg] certified by AstraZeneca AB as the reference preparation, a human bioequivalence test was conducted under fasting/postprandial conditions to evaluate the bioequivalence of the test preparation and the reference preparation in healthy subjects.
Secondary purpose: Observe the safety of the test preparation and the reference preparation in healthy subjects.
[Translation] Bioequivalence study of tadalafil tablets
主要研究目的
评价中国健康成年男性受试者空腹及餐后条件下单次单剂量口服重庆康刻尔制药股份有限公司研发的他达拉非片(受试制剂,规格:20mg)和Eli Lilly Nederland B.V.持证、Lilly del Caribe, Inc.生产的他达拉非片(参比制剂,商品名:希爱力®,规格:20mg)后的药代动力学特点和生物等效性。
次要研究目的
研究他达拉非片的受试制剂(规格:20mg)和参比制剂(商品名:希爱力®,规格:20mg)在中国健康成年男性受试者中的安全性。
[Translation] Main study objectives
To evaluate the pharmacokinetic characteristics and bioequivalence of tadalafil tablets (test preparation, specification: 20 mg) developed by Chongqing Kangkeer Pharmaceutical Co., Ltd. and tadalafil tablets (reference preparation, trade name: Cialis®, specification: 20 mg) licensed by Eli Lilly Nederland B.V. and produced by Lilly del Caribe, Inc., after a single oral dose in healthy Chinese adult male subjects under fasting and postprandial conditions.
Secondary study objectives
To study the safety of the test preparation (specification: 20 mg) and reference preparation (trade name: Cialis®, specification: 20 mg) of tadalafil tablets in healthy Chinese adult male subjects.
枸橼酸西地那非片在中国健康受试者单中心、随机、开放、单次给药、两制剂、两周期交叉人体生物等效性试验
[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-period crossover bioequivalence study of sildenafil citrate tablets in healthy Chinese subjects
以重庆康刻尔制药股份有限公司生产的枸橼酸西地那非片(规格:100mg)为受试制剂(T),按相关生物等效性试验的规定,以辉瑞制药有限公司生产的枸橼酸西地那非片(规格:100mg,商品名:万艾可®)为参比制剂(R)进行生物等效性试验。
[Translation] Sildenafil citrate tablets (specification: 100 mg) produced by Chongqing Kangkel Pharmaceutical Co., Ltd. were used as the test preparation (T), and a bioequivalence test was conducted in accordance with the relevant bioequivalence test regulations, with Sildenafil citrate tablets (specification: 100 mg, trade name: Viagra®) produced by Pfizer Pharmaceuticals Co., Ltd. as the reference preparation (R).
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