[Translation] A randomized, open-label, two-dose, two-period, double-crossover bioequivalence study of tofacitinib citrate extended-release tablets in healthy subjects under fasting and fed conditions

考察健康受试者在空腹及餐后条件下，单次口服由宁波美诺华天康药业有限公司提供的枸橼酸托法替布缓释片（受试制剂，规格：11mg）与相同条件下单次口服由Pfizer Inc.持证的枸橼酸托法替布缓释片（参比制剂，商品名：Xeljanz®/尚杰，规格：11mg）的药动学特征，评价两制剂间的生物等效性和安全性，为该受试制剂注册申请提供依据。

[Translation]

To investigate the pharmacokinetic characteristics of a single oral administration of tofacitinib citrate sustained-release tablets (test preparation, specification: 11 mg) provided by Ningbo Minova Tiankang Pharmaceutical Co., Ltd. under fasting and postprandial conditions in healthy subjects, and a single oral administration of tofacitinib citrate sustained-release tablets (reference preparation, trade name: Xeljanz®/Shangjie, specification: 11 mg) certified by Pfizer Inc. under the same conditions, to evaluate the bioequivalence and safety of the two preparations, and to provide a basis for the registration application of the test preparation.

Start Date15 Aug 2024

Sponsor / Collaborator

Ningbo Menovo TianKang Pharmaceutical Co., Ltd.

CTR20242362 / CompletedNot Applicable

评估受试制剂比拉斯汀口服溶液（规格：2.5 mg/ml）与参比制剂比拉斯汀口服溶液（规格：2.5 mg/ml）在健康成年受试者空腹状态下的单中心、开放、随机、单剂量、两周期、两序列、交叉生物等效性试验

[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study to evaluate the bioequivalence of the test preparation, bilastine oral solution (strength: 2.5 mg/ml), and the reference preparation, bilastine oral solution (strength: 2.5 mg/ml) in healthy adult subjects under fasting conditions

主要研究目的：研究空腹状态下单次口服受试制剂比拉斯汀口服溶液20 mg（规格：2.5 mg/ml，华益药业科技（安徽）有限公司生产）与参比制剂比拉斯汀口服溶液20 mg（规格：2.5 mg/ml，FAES FARMA, S.A.生产）在健康受试者体内的药代动力学，评价空腹状态口服两种制剂的生物等效性。次要研究目的：评估受试制剂比拉斯汀口服溶液20 mg（规格：2.5 mg/ml）和参比制剂比拉斯汀口服溶液20 mg（规格：2.5 mg/ml）在健康受试者中的安全性。

[Translation]

Primary study objective: To study the pharmacokinetics of a single oral dose of the test preparation Bilastine Oral Solution 20 mg (Specification: 2.5 mg/ml, produced by Huayi Pharmaceutical Technology (Anhui) Co., Ltd.) and the reference preparation Bilastine Oral Solution 20 mg (Specification: 2.5 mg/ml, produced by FAES FARMA, S.A.) in healthy subjects in the fasting state, and to evaluate the bioequivalence of the two preparations in the fasting state. Secondary study objective: To evaluate the safety of the test preparation Bilastine Oral Solution 20 mg (Specification: 2.5 mg/ml) and the reference preparation Bilastine Oral Solution 20 mg (Specification: 2.5 mg/ml) in healthy subjects.

Start Date02 Aug 2024

Sponsor / Collaborator

Ningbo Menovo TianKang Pharmaceutical Co., Ltd.

CTR20241446 / CompletedNot Applicable

评估受试制剂比拉斯汀片（规格：20 mg）与参比制剂（Bilaxten®）（规格：20 mg）在健康成年受试者空腹状态下的单中心、开放、随机、单剂量、两周期、两序列、交叉生物等效性研究

[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study to evaluate the bioequivalence of the test formulation, Bilastine Tablets (strength: 20 mg), and the reference formulation (Bilaxten®) (strength: 20 mg) in healthy adult subjects under fasting conditions

研究空腹状态下单次口服受试制剂比拉斯汀片（规格：20 mg，宁波美诺华天康药业有限公司生产）与参比制剂比拉斯汀片（Bilaxten®）（规格：20 mg，FAES FARMA, S.A.生产）在健康受试者体内的药代动力学，评价空腹状态口服两种制剂的生物等效性。次要研究目的：评估受试制剂比拉斯汀片（规格：20 mg）和参比制剂比拉斯汀片（Bilaxten®）（规格：20 mg）在健康受试者中的安全性。

[Translation]

To study the pharmacokinetics of the test preparation Bilastine Tablets (Specification: 20 mg, produced by Ningbo Menova Tiankang Pharmaceutical Co., Ltd.) and the reference preparation Bilastine Tablets (Bilaxten®) (Specification: 20 mg, produced by FAES FARMA, S.A.) in healthy subjects after a single oral administration under fasting conditions, and to evaluate the bioequivalence of the two preparations when taken orally under fasting conditions. Secondary study objectives: To evaluate the safety of the test preparation Bilastine Tablets (Specification: 20 mg) and the reference preparation Bilastine Tablets (Bilaxten®) (Specification: 20 mg) in healthy subjects.

Start Date01 Jun 2024

Sponsor / Collaborator

Ningbo Menovo TianKang Pharmaceutical Co., Ltd.

100 Clinical Results associated with Ningbo Menovo TianKang Pharmaceutical Co., Ltd.

0 Patents (Medical) associated with Ningbo Menovo TianKang Pharmaceutical Co., Ltd.

100 Deals associated with Ningbo Menovo TianKang Pharmaceutical Co., Ltd.

100 Translational Medicine associated with Ningbo Menovo TianKang Pharmaceutical Co., Ltd.

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