Delving into the Latest Updates on Jilin Wutai Gankang Pharmaceutical Co. Ltd. with Synapse

Overview

主要研究目的：考察单次口服75mg（空腹/餐后）受试制剂磷酸奥司他韦胶囊（规格：75mg/粒，吉林省吴太感康药业有限公司生产）与参比制剂磷酸奥司他韦胶囊（达菲®，规格：75mg/粒，意大利Roche S.p.A.生产），在中国健康人体的相对生物利用度，分析两种制剂的药代动力学参数，评价两制剂的生物等效性，为该药的申报及临床用药提供参考依据。次要研究目的：评价受试制剂和参比制剂单次口服75mg（空腹/餐后）在中国健康成年受试者中的安全性。

[Translation]

The main purpose of the study is to investigate the relative bioavailability of a single oral dose of 75 mg (fasting/after meals) of the test preparation Oseltamivir Phosphate Capsules (Specification: 75 mg/capsule, produced by Jilin Wutaigankang Pharmaceutical Co., Ltd.) and the reference preparation Oseltamivir Phosphate Capsules (Tamiflu®, Specification: 75 mg/capsule, produced by Roche S.p.A., Italy) in healthy Chinese subjects, analyze the pharmacokinetic parameters of the two preparations, evaluate the bioequivalence of the two preparations, and provide a reference for the application and clinical use of the drug. Secondary purpose of the study: To evaluate the safety of a single oral dose of 75 mg (fasting/after meals) of the test preparation and the reference preparation in healthy Chinese adult subjects.

Start Date09 Aug 2022

Sponsor / Collaborator

Jilin Wutai Gankang Pharmaceutical Co. Ltd.

CTR20250407

/ Not yet recruitingNot Applicable

磷酸奥司他韦干混悬剂在中国成年健康受试者中的随机、开放、空腹和餐后单次给药、两制剂、两序列、两周期交叉的生物等效性研究

[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, two-period crossover bioequivalence study of oseltamivir phosphate suspension in healthy adult Chinese subjects

主要研究目的：考察空腹/餐后单次口服75mg受试制剂磷酸奥司他韦干混悬剂[规格：0.36g（按C16H28N2O4计），吉林省吴太感康药业有限公司生产]与参比制剂磷酸奥司他韦干混悬剂[商品名：Tamiflu，规格：6mg/ml（按C16H28N2O4计）；Hoffmann La Roche Inc生产]，在中国成年健康人体的相对生物利用度，分析两种制剂的药代动力学参数，评价两制剂的生物等效性。次要研究目的：评价空腹/餐后单次口服受试制剂和参比制剂在中国成年健康受试者中的安全性。

[Translation]

Main study objectives: To investigate the relative bioavailability of a single oral dose of 75 mg of the test preparation oseltamivir phosphate dry suspension [specification: 0.36 g (calculated as C16H28N2O4), produced by Jilin Wutaigankang Pharmaceutical Co., Ltd.] and the reference preparation oseltamivir phosphate dry suspension [trade name: Tamiflu, specification: 6 mg/ml (calculated as C16H28N2O4); produced by Hoffmann La Roche Inc] in healthy Chinese adults, analyze the pharmacokinetic parameters of the two preparations, and evaluate the bioequivalence of the two preparations. Secondary study objectives: To evaluate the safety of a single oral dose of the test preparation and the reference preparation in healthy Chinese adults.

Start Date-

Sponsor / Collaborator

Jilin Wutai Gankang Pharmaceutical Co. Ltd.

CTR20221323

/ Not yet recruitingNot Applicable

磷酸奥司他韦胶囊在中国健康成年受试者中的一项随机、开放、空腹和餐后单次给药、两制剂、两序列、两周期交叉的生物等效性研究

[Translation] A randomized, open-label, single-dose, fasting and fed, two-formulation, two-sequence, two-period crossover bioequivalence study of oseltamivir phosphate capsules in healthy Chinese adult subjects

主要研究目的：考察单次口服75mg（空腹/餐后）受试制剂磷酸奥司他韦胶囊（规格：75mg/粒，吉林省吴太感康药业有限公司生产）与参比制剂磷酸奥司他韦胶囊（达菲®，规格：75mg/粒，意大利Roche S.p.A.生产），在中国健康人体的相对生物利用度，分析两种制剂的药代动力学参数，评价两制剂的生物等效性，为该药的申报及临床用药提供参考依据。次要研究目的：评价受试制剂和参比制剂单次口服75mg（空腹/餐后）在中国健康成年受试者中的安全性。

[Translation]

The main purpose of the study is to investigate the relative bioavailability of a single oral dose of 75 mg (fasting/after meals) of the test preparation Oseltamivir Phosphate Capsules (Specification: 75 mg/capsule, produced by Jilin Wutaigankang Pharmaceutical Co., Ltd.) and the reference preparation Oseltamivir Phosphate Capsules (Tamiflu®, Specification: 75 mg/capsule, produced by Roche S.p.A., Italy) in healthy Chinese subjects, analyze the pharmacokinetic parameters of the two preparations, evaluate the bioequivalence of the two preparations, and provide a reference for the application and clinical use of the drug. Secondary purpose of the study: To evaluate the safety of a single oral dose of 75 mg (fasting/after meals) of the test preparation and the reference preparation in healthy Chinese adult subjects.

Start Date-

Sponsor / Collaborator

Jilin Wutai Gankang Pharmaceutical Co. Ltd.

100 Clinical Results associated with Jilin Wutai Gankang Pharmaceutical Co. Ltd.

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0 Patents (Medical) associated with Jilin Wutai Gankang Pharmaceutical Co. Ltd.

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100 Deals associated with Jilin Wutai Gankang Pharmaceutical Co. Ltd.

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100 Translational Medicine associated with Jilin Wutai Gankang Pharmaceutical Co. Ltd.

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