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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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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.Japan |
First Approval Date27 May 1983 |
Target- |
Mechanism- |
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Inactive Indication- |
Drug Highest PhaseNDA/BLA |
First Approval Ctry. / Loc.- |
First Approval Date- |
/ Not yet recruitingNot 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.
/ Not yet recruitingNot Applicable 马来酸阿伐曲泊帕片在中国健康志愿者的人体生物等效性试验
[Translation] Human bioequivalence study of avatrombopag maleate tablets in Chinese healthy volunteers
主要目的: 研究受试制剂马来酸阿伐曲泊帕片(规格:20mg)与参比制剂马来酸阿伐曲泊帕片(Doptelet/苏可欣,规格:20mg)在健康成年受试者体内的药代动力学特征,评价口服两种制剂的生物等效性。 次要目的: 研究受试制剂马来酸阿伐曲泊帕片(规格:20 mg)和参比制剂马来酸阿伐曲泊帕片(Doptelet/苏可欣)(规格:20 mg)在健康受试者中的安全性。
[Translation] Primary objective: To study the pharmacokinetic characteristics of the test preparation avatrombopag maleate tablets (specification: 20 mg) and the reference preparation avatrombopag maleate tablets (Doptelet/Su Kexin, specification: 20 mg) in healthy adult subjects, and to evaluate the oral bioequivalence of the two preparations. Secondary objective: To study the safety of the test preparation avatrombopag maleate tablets (specification: 20 mg) and the reference preparation avatrombopag maleate tablets (Doptelet/Su Kexin) (specification: 20 mg) in healthy subjects.
100 Clinical Results associated with Bozhiyan New Taizhou Pharmaceutical Technology Co., Ltd.
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