[Translation] Bioequivalence of doxazosin mesylate tablets in healthy volunteers under fasting conditions
主要目标:为了证明受试制剂(T):安若维他药业泰州有限公司生产的甲磺酸多沙唑嗪片4mg,与参比制剂(R):Roerig Division of Pfizer Inc, USA的Cardura® (甲磺酸多沙唑嗪)片4mg之间,在空腹条件下作用于32名健康、成年、男性&女性、人体受试者的生物等效性。
次要目标:监测受试者口服单剂量研究产品(IPs)的安全性和有效性
[Translation] Primary objective: To demonstrate the bioequivalence between the test product (T): Doxazosin Mesylate Tablets 4 mg produced by Anruovita Pharmaceuticals Taizhou Co., Ltd. and the reference product (R): Cardura® (Doxazosin Mesylate) Tablets 4 mg produced by Roerig Division of Pfizer Inc, USA, in 32 healthy, adult, male & female, human subjects under fasting conditions.
Secondary objective: To monitor the safety and efficacy of single oral doses of investigational products (IPs) in subjects
[Translation] Bioequivalence of doxazosin mesylate tablets in healthy volunteers under fed conditions
主要目标:为了证明受试制剂(T):安若维他药业泰州有限公司生产的甲磺酸多沙唑嗪片4mg,与参比制剂(R):Roerig Division of Pfizer Inc, USA的Cardura® (甲磺酸多沙唑嗪)片4mg之间,在餐后条件下作用于32名健康、成年、男性&女性、人体受试者的生物等效性。
次要目标:监测受试者口服单剂量研究产品(IPs)的安全性和有效性。
[Translation] Primary objective: To demonstrate the bioequivalence between the test product (T): Doxazosin Mesylate Tablets 4 mg produced by Anruovita Pharmaceuticals Taizhou Co., Ltd. and the reference product (R): Cardura® (Doxazosin Mesylate) Tablets 4 mg produced by Roerig Division of Pfizer Inc, USA, in 32 healthy, adult, male & female, human subjects under fed conditions.
Secondary objective: To monitor the safety and efficacy of single oral doses of investigational products (IPs) in subjects.
[Translation] Bioequivalence study of perindopril tert-butylamine tablets in healthy volunteers under fed conditions
主要目标:为了证明受试制剂(T):安若维他药业泰州有限公司生产的培哚普利叔丁胺片(8mg),与参比制剂(R):施维雅(天津)制药有限公司生产的Acertil®培哚普利叔丁胺片(8mg)之间,在餐后条件下作用于42名健康、成年、男性&女性、人体受试者的生物等效性。 次要目标:监测受试者口服单剂量研究产品(IPs)的安全性和有效性。
[Translation] Primary objective: To demonstrate the bioequivalence between the test product (T): Perindopril tert-butylamine tablets (8 mg) produced by Anruovita Pharmaceuticals Taizhou Co., Ltd. and the reference product (R): Acertil® Perindopril tert-butylamine tablets (8 mg) produced by Servier (Tianjin) Pharmaceuticals Co., Ltd., in 42 healthy, adult, male & female, human subjects under fed conditions. Secondary objective: To monitor the safety and efficacy of single oral doses of investigational products (IPs) in subjects.
100 Clinical Results associated with Anruowita Pharmaceutical Taizhou Co., Ltd.
0 Patents (Medical) associated with Anruowita Pharmaceutical Taizhou Co., Ltd.
100 Deals associated with Anruowita Pharmaceutical Taizhou Co., Ltd.
100 Translational Medicine associated with Anruowita Pharmaceutical Taizhou Co., Ltd.