[Translation] A single-center, randomized, open-label, two-dose, fasting and postprandial, single-dose, two-period, double-crossover bioequivalence study of empagliflozin tablets developed by Guangdong PBIDI Pharmaceutical Co., Ltd. and the original reference formulation in healthy Chinese subjects

以广东彼迪药业有限公司研制的恩格列净片（规格：25 mg）为受试制剂，持证商为Boehringer Ingelheim International GmbH的恩格列净片（商品名：Jardiance®，规格：25 mg）为参比制剂，考察两制剂在空腹及餐后状态下单次给药的药代动力学参数及相对生物利用度，评价两制剂是否具有生物等效性。同时评价两种制剂在健康人体中的安全性和耐受性。

[Translation]

The empagliflozin tablets (specification: 25 mg) developed by Guangdong BIDI Pharmaceutical Co., Ltd. were used as the test preparation, and the empagliflozin tablets (trade name: Jardiance®, specification: 25 mg) licensed by Boehringer Ingelheim International GmbH were used as the reference preparation. The pharmacokinetic parameters and relative bioavailability of the two preparations after single administration in the fasting and postprandial states were investigated to evaluate whether the two preparations were bioequivalent. At the same time, the safety and tolerability of the two preparations in healthy humans were evaluated.

Start Date15 Oct 2024

Sponsor / Collaborator

Guangdong Pidi Pharmaceutical Co., Ltd.

CTR20242987

/ CompletedNot Applicable

阿昔洛韦片在健康受试者中随机、开放、两制剂、单次给药、两周期、两序列空腹和餐后状态下的生物等效性试验

[Translation] A randomized, open-label, two-dose, single-dose, two-cycle, two-sequence bioequivalence study of acyclovir tablets in healthy subjects under fasting and fed conditions

主要目的：以广东彼迪药业有限公司提供的阿昔洛韦片为受试制剂，按生物等效性试验的有关规定，与Glaxo Smithkline K.K.持有グラクソ·スミスクライソ株式会社生产的阿昔洛韦片（商品名：Zovirax®，参比制剂）对比在健康人体内的吸收速度及吸收程度，考察两制剂的人体生物等效性。次要目的：观察受试制剂阿昔洛韦片和参比制剂阿昔洛韦片（Zovirax®）在健康受试者中的安全性。

[Translation]

Main purpose: Using acyclovir tablets provided by Guangdong BIDI Pharmaceutical Co., Ltd. as the test preparation, according to the relevant provisions of the bioequivalence test, the absorption rate and degree of acyclovir tablets (trade name: Zovirax®, reference preparation) produced by Glaxo Smithkline K.K. and Glaxo Smithkline Co., Ltd. were compared in healthy subjects to investigate the bioequivalence of the two preparations. Secondary purpose: To observe the safety of the test preparation acyclovir tablets and the reference preparation acyclovir tablets (Zovirax®) in healthy subjects.

Start Date26 Aug 2024

Sponsor / Collaborator

Guangdong Pidi Pharmaceutical Co., Ltd.

CTR20241826

/ CompletedNot Applicable

阿哌沙班片随机、开放、单剂量、两制剂、两周期、两序列、交叉设计在健康受试者空腹和餐后状态下生物等效性试验

[Translation] A randomized, open-label, single-dose, two-formulation, two-period, two-sequence, crossover-design bioequivalence study of apixaban tablets in healthy subjects under fasting and fed conditions

主要目的：评价健康受试者在空腹和餐后状态下口服广东彼迪药业有限公司生产的受试制剂阿哌沙班片与Bristol-Myers Squibb Company生产的参比制剂阿哌沙班片（Eliquis®）后是否具有生物等效性。次要目的：观察受试制剂阿哌沙班片与参比制剂阿哌沙班片（Eliquis®）在健康受试者中的安全性。

[Translation]

Primary objective: To evaluate whether the test preparation of apixaban tablets produced by Guangdong BIDI Pharmaceutical Co., Ltd. and the reference preparation of apixaban tablets (Eliquis®) produced by Bristol-Myers Squibb Company are bioequivalent after oral administration in healthy subjects in fasting and fed state. Secondary objective: To observe the safety of the test preparation of apixaban tablets and the reference preparation of apixaban tablets (Eliquis®) in healthy subjects.

Start Date11 Jul 2024

Sponsor / Collaborator

Guangdong Pidi Pharmaceutical Co., Ltd.

100 Clinical Results associated with Guangdong Pidi Pharmaceutical Co., Ltd.

0 Patents (Medical) associated with Guangdong Pidi Pharmaceutical Co., Ltd.

Literatures (Medical) associated with Guangdong Pidi Pharmaceutical Co., Ltd.

01 Aug 2020·Bioorganic Chemistry

A novel multifunctional 2-nitroimidazole-based bioreductive linker and its application in hypoxia-activated prodrugs

Article

Author: Lu, Wei ; Jin, Chen ; Yu, Jiahui ; Huang, Ying ; Wang, Lei

Tumor hypoxia has been widely explored over the years as a diagnostic and therapeutic marker. Herein, we designed, optimized and synthesized a new multifunctional bioreductive linker (12) containing an alkynyl group (potential click chemistry fragment); the linker is based on 2-nitroimidazole which was expected to simultaneously overcome the drawbacks of hypoxia-activated prodrugs (poor selectivity and unsatisfactory water solubility). Furthermore, a hypoxia-activated, water-soluble SN-38 prodrug was obtained, and it was stable under physiological conditions and was rapidly released as an active drug under hypoxic conditions.

02 Oct 2016·Drug Development and Industrial PharmacyQ4 · MEDICINE

Development and validation of dissolution testings in acidic media for rabeprazole sodium delayed-release capsules

Q4 · MEDICINE

Article

Author: Feng, Xin ; Zhong, Lulu ; Yang, Xinmin ; Tan, Yinhe ; Huang, Min ; Si, Xiaoqing ; Wu, Chuanbin

Rabeprazole sodium (RAB) dissolved in acidic media is accompanied by its degradation in the course of dissolution testing. To develop and establish the accumulative release profiles of ACIPHEX(®) Sprinkle (RAB) delayed-release capsules (ACIPHEX(®) Sprinkle) in acidic media using USP apparatus 2 (paddle apparatus) as a dissolution tester, the issues of determination of accumulative release amount of RAB in these acidic media and interference of hydroxypropylmethyl cellulose phthalate were solved by adding appropriate hydrochloric acid (HCl) into dissolution samples coupled with centrifugation so as to remove the interference and form a solution of degradation products of RAB, which is of a considerably stable ultraviolet (UV) absorbance at the wavelength of 298 nm within 2.0 h. Therefore, the accumulative release amount of RAB in dissolution samples at each sample time points could be determined by UV-spectrophotometry, and the accumulative release profiles of ACIPHEX(®) Sprinkle in the media of pH 1.0, pH 6.0, and pH 6.8 could be established. The method was validated per as the ICH Q2 (R1) guidelines and demonstrated to be adequate for quality control of ACIPHEX(®) Sprinkle and the accumulative release profiles can be used as a tool to guide the formulation development and quality control of a generic drug for ACIPHEX(®) Sprinkle.

Zhongguo Yaopin Biaozhun

Determination of the absolute content of dihydromyricetin based on proton nuclear magnetic resonance

Author: Zhang Hongqin

Objective: To establish a quant. NMR(qNMR) method to determine the absolute content of dihydromyricetin.Method: CD_3OD was used as the solvent and maleic acid as an internal standardThe content of dihydromyricetin was determined by comparing the response signal areas of the internal standard(maleic, δ6.33 ppm) and dihydromyricetin(δ6.59-6.65 ppm).The content results of dihydromyricetin determined by qNMR and mass balance method were also compared.Results: The concentration of dihydromyricetin(1.03-10.12 mg·mL∼(-1)) and the peak area of quantification peaks showed a good linear regression.The regression equation was Y=2.411 6X-0.092 7(r=0. 999 1).The precision RSD was 0.62%, the average recovery was 97.96% and the RSD of repeatability was 1.82%.The contents of three batches dihydromyricetin were 93.64%, 93.08% and 93.81% resp., which were generally consistent with that of mass balance method.Conclusion: The established qNMR method is simple and has less test time.It could be employed to the quant. determination of dihydromyricetin.

100 Deals associated with Guangdong Pidi Pharmaceutical Co., Ltd.

100 Translational Medicine associated with Guangdong Pidi Pharmaceutical Co., Ltd.

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