[Translation] Bioequivalence trial 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 research purpose
Evaluation of the oral administration of a single dose of Tadalafil tablets (test preparation, specification: 20 mg) developed by Chongqing Kangker Pharmaceutical Co., Ltd. and Eli Lilly Nederland B.V. licensed to Chinese healthy adult male subjects under fasting and postprandial conditions , pharmacokinetic characteristics and bioequivalence of tadalafil tablets (reference preparation, trade name: Cialis®, strength: 20 mg) produced by Lilly del Caribe, Inc.
Secondary research purpose
To study the safety of the test preparation (specification: 20mg) and reference preparation (trade name: Cialis®, specification: 20mg) 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] Single-center, randomized, open-label, single-dose, two-drug, two-cycle crossover human bioequivalence study of sildenafil citrate tablets in Chinese healthy 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: 100mg) produced by Chongqing Kangkeer Pharmaceutical Co., Ltd. Sildenafil citrate tablets (specification: 100mg, trade name: Viagra®) were used as the reference preparation (R) for the bioequivalence test.
[Translation] Human Bioequivalence Test of Telmisartan Tablets under Fasting and Postprandial Conditions
本研究考察健康受试者在空腹及餐后条件下,单次口服由重庆康刻尔制药股份有限公司生产的替米沙坦片(受试制剂,规格:40 mg)或由 Boehringer Ingelheim International GmbH 持证的替米沙坦片(参比制剂,商品名:Micardis®,规格:40 mg)的药动学特征,评价两制剂的生物等效性及安全性,为该受试制剂注册申请提供依据。
[Translation] In this study, healthy volunteers took a single oral administration of telmisartan tablets (test formulation, specification: 40 mg) produced by Chongqing Kangkeer Pharmaceutical Co., Ltd. or Boehringer Ingelheim International GmbH under fasting and postprandial conditions Pharmacokinetic characteristics of licensed telmisartan tablets (reference preparation, trade name: Micardis®, strength: 40 mg), evaluate the bioequivalence and safety of the two preparations, and provide for the registration application of the test preparation in accordance with.
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