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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 |
/ 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.
/ CompletedNot Applicable 达普司他片在中国健康受试者中空腹及餐后状态下的人体生物等效性研究
[Translation] A human bioequivalence study of dapnostat tablets in Chinese healthy subjects under fasting and fed conditions
主要目的:
观察达普司他片在中国健康受试者中单次口服给药后达普司他的体内药 代动力学过程,估算相应的药代动力学参数,并以グラクソ·スミスクライ ン株式会社持证,在日本上市的达普司他片(商品名:Duvroq)作为原剂型参比制 剂,进行人体生物等效性评价。
次要目的:
观察达普司他片在健康人体中的安全性。
[Translation] Primary objective:
To observe the in vivo pharmacokinetic process of dapnostat tablets after a single oral administration in healthy Chinese subjects, estimate the corresponding pharmacokinetic parameters, and use dapnostat tablets (trade name: Duvroq) licensed by Grakuso Smiscline Co., Ltd. and marketed in Japan as the original dosage form reference preparation for human bioequivalence evaluation.
Secondary objective:
To observe the safety of dapnostat tablets in healthy humans.
[Translation] Food Effect Study of BCM894 Capsules in Chinese Healthy Subjects
(1)主要目的:
观察在健康受试者中空腹和餐后状态下分别单次给予BCM894胶囊的药代动力学特征,考察食物对BCM894胶囊药代动力学的影响。
(2)次要目的:
观察BCM894胶囊在中国健康受试者中的安全性。
[Translation] (1) Primary objective:
To observe the pharmacokinetic characteristics of BCM894 capsules after single administration in healthy subjects in the fasting and fed states, and to investigate the effect of food on the pharmacokinetics of BCM894 capsules.
(2) Secondary objective:
To observe the safety of BCM894 capsules in healthy Chinese subjects.
100 Clinical Results associated with Shanghai Bozhiyanxin Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Shanghai Bozhiyanxin Pharmaceutical Co., Ltd.
100 Deals associated with Shanghai Bozhiyanxin Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Shanghai Bozhiyanxin Pharmaceutical Co., Ltd.