[Translation] A randomized, open-label, single-dose, two-period, double-crossover, fasting/fed bioequivalence study of olopatadine hydrochloride tablets in healthy subjects

以中国健康受试者为试验对象，采用自身交叉对照的试验设计，测定江苏亚邦爱普森药业有限公司持证生产的盐酸奥洛他定片给药后血浆中的奥洛他定在健康受试者体内的血药浓度经时过程，估算相应的药代动力学参数，并以协和麒麟株式会社（Kyowa Kirin Co.,Ltd）持证生产的盐酸奥洛他定片【商品名：阿洛刻（Allelock）®，规格：5mg】为参比，评价制剂间的生物等效性，并观察盐酸奥洛他定片在中国健康受试者中的安全性。

[Translation]

Healthy Chinese subjects were used as test subjects. A self-crossover design was used to determine the time course of olopatadine concentration in plasma after administration of olopatadine hydrochloride tablets produced under license by Jiangsu Yabang Epson Pharmaceutical Co., Ltd., and to estimate the corresponding pharmacokinetic parameters. Olopatadine hydrochloride tablets [trade name: Allelock®, specification: 5 mg] produced under license by Kyowa Kirin Co., Ltd. were used as reference to evaluate the bioequivalence between the preparations and to observe the safety of olopatadine hydrochloride tablets in healthy Chinese subjects.

Start Date07 May 2024

Sponsor / Collaborator

Jiangsu Yabang Epson Pharmaceutical Co Ltd.

CTR20233417 / CompletedNot Applicable

替米沙坦片在健康受试者中的单中心、随机、开放、两制剂、四周期、两序列、完全重复交叉空腹及餐后生物等效性研究

[Translation] A single-center, randomized, open-label, two-dose, four-period, two-sequence, completely repeated crossover fasting and fed bioequivalence study of telmisartan tablets in healthy subjects

主要研究目的：以江苏省亚邦爱普森药业有限公司研制的替米沙坦片（规格：80 mg）为受试制剂，与Boehringer Ingelheim International GmbH持证的替米沙坦片（商品名：美卡素®/Micardis®，规格：80 mg）为参比制剂，研究受试制剂和参比制剂在空腹和高脂餐后条件下给药后的药代动力学参数，进行人体生物等效性评价。次要研究目的：观察受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

The main purpose of the study was to use the Telmisartan Tablets (Specification: 80 mg) developed by Jiangsu Yabang Epson Pharmaceutical Co., Ltd. as the test preparation and the Telmisartan Tablets (trade name: Micardis®/Micardis®, Specification: 80 mg) certified by Boehringer Ingelheim International GmbH as the reference preparation to study the pharmacokinetic parameters of the test preparation and the reference preparation after administration under fasting and high-fat meal conditions, and to evaluate the bioequivalence in humans. The secondary purpose of the study was to observe the safety of the test preparation and the reference preparation in healthy subjects.

Start Date08 Nov 2023

Sponsor / Collaborator

Jiangsu Yabang Epson Pharmaceutical Co Ltd.

CTR20222314 / CompletedNot Applicable

盐酸地芬尼多片在健康受试者中随机、开放、单次给药、两周期、双交叉空腹和餐后生物等效性试验

[Translation] A randomized, open-label, single-dose, two-period, double-crossover bioequivalence study of difenidol hydrochloride tablets in healthy subjects on fasting and fed diet

主要研究目的：以江苏亚邦爱普森药业有限公司研制的盐酸地芬尼多片（规格：25 mg）为受试制剂，按生物等效性研究的有关规定，与日本新药株式会社生产的盐酸地芬尼多片（参比制剂，商品名：Cephadol®，规格：25 mg）对比在健康人体内的药代动力学特征，考察两制剂的人体生物等效性。次要研究目的：考察盐酸地芬尼多片受试制剂（规格：25 mg）和参比制剂（商品名：Cephadol ®，规格：25 mg）在健康受试者中的安全性。

[Translation]

The main purpose of the study: Using the difenidol hydrochloride tablets (specification: 25 mg) developed by Jiangsu Yabang Epson Pharmaceutical Co., Ltd. as the test preparation, according to the relevant provisions of the bioequivalence study, the pharmacokinetic characteristics of the difenidol hydrochloride tablets (reference preparation, trade name: Cephadol®, specification: 25 mg) produced by Japan Shinyaku Co., Ltd. were compared in healthy humans to investigate the bioequivalence of the two preparations. Secondary purpose of the study: To investigate the safety of the test preparation of difenidol hydrochloride tablets (specification: 25 mg) and the reference preparation (trade name: Cephadol®, specification: 25 mg) in healthy subjects.

Start Date12 Oct 2022

Sponsor / Collaborator

Jiangsu Yabang Epson Pharmaceutical Co Ltd.

100 Clinical Results associated with Changzhou Yabang Pharmaceutical Co., Ltd.

0 Patents (Medical) associated with Changzhou Yabang Pharmaceutical Co., Ltd.

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Jingxi Huagong

Synthesis of 2-(n-Propyl)-4-methyl-6-methoxycarbonylbenzimidazole in fluorous biphasic system (FBS)

Author: Yi, Wenbin ; Tao, Feng

2-(N-Propyl) 4-methyl-6-methoxycarbonylbenzimidazole (I) is an important intermediate of telmisartan pharmaceutical.3-Methyl-4-butylamino-5-aminobenzoate was efficiently converted into I in fluorous biphasic system (FBS) without acetic acid.It was found that Yb(OPf)₃ and C₁₀F₁₈ were the best catalyst and fluorous solvent resp. for the reaction.Yield of I could be up to 94% at 80° for 2 h with x [Yb(OPf)₃] = 0.3%.By simple phase separation, the fluorous phase containing only the catalyst could be directly reused next time.Based on ¹⁹F NMR and UV-Vis and GC-MS data, no loss of catalyst or fluorous solvent to the organic phase could be detected, and no organic compounds could be found in the fluorous phase.There was no significant difference between the UV-Vis spectra of the initial and recovered fluorous phases, indicating that Yb(OPf)₃ was recovered unaltered after the condensation reaction.The catalyst was completely (> 99%) recovered as determined by at. emission spectrometry.The fluorous phase containing only catalyst could be reused up to ten times with only a slight decrease in yields from 94% to 90%.

Zhongguo Yiyao Gongye Zazhi

Synthesis of 2-propyl-4-methyl-6-(1-methylbenzimidazol-2-yl)-benzimidazole

Author: Yi, Wenbin ; Tao, Feng

A method for the synthesis of the title compound is reported here.That compound is an important intermediate for telmisartan.A reaction of 7-methyl-2-propyl-1H-benzimidazole-5-carboxylic acid with N-methyl-1,2-benzenediamine was achieved in the presence of a polyphosphoric acid-free biphasic system using 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-1-octanesulfonic acid ytterbium salt as catalyst.That catalyst could be re-used by simple a phase-separation method.

Yaowu Fenxi Zazhi

Determination of degradation products of adefovir dipivoxil by ion-pair HPLC

Author: Jiang, Fei-ying ; Zhu, Feng ; Chen, Zai-xin ; Wang, Yong-jun ; Li, Xiao-bing ; Mao, Bai-yang

A method for the determination of main degradation products including mono-POM PMEA, adefovir and other impurities in adefovir dipivoxil was established.The Welch Materials XB-C₈ column (250 mm × 4.6 mm, 5 μm) was adopted with the mobile phase consisting of buffer solution-acetonitrile (65:35), the buffer solution contained 50 mmol · L^-1 potassium phosphate dibasic and 10 mmol · L^-1 tetrabutylammonium hydrogen sulfate, and was adjusted to pH 3.0 with phosphate acid.The detection wavelength was 260 nm, and the flow rate was 1.0 mL · min^-1.The baseline separation was achieved between the main peak of adefovir dipivoxil and the near peak of impurities, and the resolutions among the main degradation products (i.e., adefovir, mono-POM PMEA and 9-[2-(diethyl-phosphonomethoxy)ethyl]adenine) were above 2.0.The good linearity was obtained over the range of 0.109-21.8 μg · mL^-1 for adefovir, 0.111-22.2 μg · mL^-1 for mono-POM PMEA, and 0.105-21.0 μg · mL^-1 for adefovir dipivoxil.The average recoveries were 98.8% for adefovir and 99.7% for mono-POM PMEA, resp.This method is simple, accurate, with well specificity, and can be applied to determination of the relative substances in adefovir dipivoxil and quality control.

100 Deals associated with Changzhou Yabang Pharmaceutical Co., Ltd.

100 Translational Medicine associated with Changzhou Yabang Pharmaceutical Co., Ltd.

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