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Drug Highest PhaseApproved |
First Approval Ctry. / Loc. |
First Approval Date13 Jan 2016 |
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Mechanism5-HT1A receptor agonists [+2] |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.United States |
First Approval Date10 Jul 2015 |
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MechanismSodium channels blockers |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc. |
First Approval Date29 Aug 2008 |
/ Active, not recruitingPhase 1 BCM476胶囊与盐酸奈必洛尔片及苯磺酸氨氯地平片的药代动力学比较研究
[Translation] Comparative pharmacokinetic study of BCM476 capsules with nebivolol hydrochloride tablets and amlodipine besylate tablets
主要目的
观察BCM476胶囊在中国健康受试者中单次口服给药后体内动力学过程,估算相应的药代动力学参数,并以盐酸奈必洛尔片(NEBILETTM)和苯磺酸氨氯地平片(络活喜®),进行药代动力学比较研究,以确定本品中的活性成份不存在药代动力学相互作用。 次要研究目的
观察BCM476胶囊受试制剂(T)和对照制剂(R1)盐酸奈必洛尔片以及对照制剂(R2)苯磺酸氨氯地平片在中国健康人体中的安全性。
[Translation] Primary Objective: To observe the pharmacokinetic process of BCM476 capsules in healthy Chinese subjects after a single oral administration, estimate the corresponding pharmacokinetic parameters, and conduct a pharmacokinetic comparison study with nebivolol hydrochloride tablets (NEBILET™) and amlodipine besylate tablets (Norvasc®) to determine that there are no pharmacokinetic interactions between the active ingredients in this product. Secondary Objective: To observe the safety of the test formulation (T) and control formulations (R1) nebivolol hydrochloride tablets and (R2) amlodipine besylate tablets in healthy Chinese subjects.
[Translation] Comparative study on the pharmacokinetics of BCM863 tablets and other single drugs
[Translation] Comparative study on the pharmacokinetics of BCM863 tablets and other single drugs
/ CompletedNot Applicable 枸橼酸西地那非口溶膜在中国健康志愿者中空腹及餐后状态下的人体生物等效性试验
[Translation] Bioequivalence study of sildenafil citrate orodispersible film in Chinese healthy volunteers under fasting and fed conditions
主要目的
研究空腹和餐后状态下单次口服受试制剂枸橼酸西地那非口溶膜(规格:50mg)与参比制剂枸橼酸西地那非口溶膜(商品名:Viagra®,规格:50mg)在中国男性健康受试者体内的药代动力学,评价空腹和餐后状态口服两种制剂的生物等效性。
次要目的
1、观察枸橼酸西地那非口溶膜受试制剂和参比制剂在男性健康受试者中的安全性。
2、评价枸橼酸西地那非口溶膜受试制剂及参比制剂的口感(适口性)、口腔的溶化时间、黏膜粘附性和刺激性等。
[Translation] Main purpose
To study the pharmacokinetics of a single oral dose of the test preparation of sildenafil citrate orodispersible film (specification: 50 mg) and the reference preparation of sildenafil citrate orodispersible film (trade name: Viagra®, specification: 50 mg) in healthy male subjects in China under fasting and fed conditions, and to evaluate the bioequivalence of the two preparations when taken orally under fasting and fed conditions.
Secondary purpose
1. To observe the safety of the test preparation of sildenafil citrate orodispersible film and the reference preparation in healthy male subjects.
2. To evaluate the taste (palatability), oral dissolution time, mucosal adhesion and irritation of the test preparation of sildenafil citrate orodispersible film and the reference preparation.
100 Clinical Results associated with Shanghai Bozhiyanxin Pharmaceutical Co., Ltd.
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