[Translation] A single-center, randomized, open-label, fasting and fed single-dose, two-formulation, two-sequence, two-period crossover bioequivalence study of faropenem sodium granules in healthy Chinese adult subjects

小儿法罗培南钠颗粒在中国成年健康受试者中的一项单中心、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 single-center, randomized, open-label, single-dose, two-formulation, two-sequence, two-period crossover bioequivalence study of faropenem sodium granules in Chinese healthy adult subjects

Start Date-

Sponsor / Collaborator

Haikou Pharmaceutical Factory Co., Ltd

CTR20233597

/ CompletedNot Applicable

富马酸伏诺拉生片在健康受试者中随机、开放、两制剂、单次给药、两周期、双交叉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-period, double-crossover bioequivalence study of vonoprazan fumarate tablets in healthy subjects under fasting and fed conditions

主要目的：以海口市制药厂有限公司研制的富马酸伏诺拉生片为受试制剂，以Takeda Pharmaceutical Company Limited持证的富马酸伏诺拉生片（商品名：沃克）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。次要目的：评价中国健康受试者单次空腹/餐后口服富马酸伏诺拉生片受试制剂和参比制剂后的安全性

[Translation]

Main purpose: To use the vonoprazan fumarate tablets developed by Haikou Pharmaceutical Factory Co., Ltd. as the test preparation and the vonoprazan fumarate tablets (trade name: Walker) certified by Takeda Pharmaceutical Company Limited as the reference preparation, to investigate the pharmacokinetic parameters and relative bioavailability of the two preparations after single administration in the fasting and postprandial state, and to evaluate whether the two preparations are bioequivalent. Secondary purpose: To evaluate the safety of the test preparation and reference preparation of vonoprazan fumarate tablets after a single oral administration in fasting/postprandial state in healthy Chinese subjects

Start Date13 Dec 2023

Sponsor / Collaborator

Haikou Pharmaceutical Factory Co., Ltd

100 Clinical Results associated with Haikou Pharmaceutical Factory Co., Ltd

0 Patents (Medical) associated with Haikou Pharmaceutical Factory Co., Ltd

Literatures (Medical) associated with Haikou Pharmaceutical Factory Co., Ltd

04 Sep 2024·Current Analytical Chemistry

Polygonum hydropiper Leaves have More Medicinal Value than Stems: Based on Chemical Composition and Antioxidant Activity

Author: Jiang, Zixiao ; Zhuang, Zhong ; Liu, Yangyang ; Wang, Meiran ; Liu, Weirui ; Hou, Wencheng

Background:Polygonum hydropiper, a traditional Chinese herbal medicine, contains abundant volatile components and effective ingredients such as flavonoids, exerting antiinflammatory, antioxidant and antibacterial effects. The pharmacologically active components are differentially distributed in different parts of P. hydropiper. Leaf loss commonly occurs during the processing of medicinal and edible products.Methods:In the present study, the total flavonoid content and DPPH antioxidant activity of the stems and leaves of P. hydropiper were compared and analyzed. A method for determining the content of six antioxidant-active components in P. hydropiper stems and leaves was established based on highperformance liquid chromatography. Simultaneously, the contents of volatile compounds in stems and leaves were determined using gas chromatography–mass spectrometry, and the compositional differences between stem and leaf extracts of P. hydropiper were analyzed. This study aims to develop and validate an analytical method based on combined HPLC and GC-MS analysis of the constituents of P. hydropiper, and to compare the differences in constituents in different tissues of P. hydropiper using the method.objective:Explore the differences in pharmacodynamic components and content of different tissue sites, and clarify the site of concentration of pharmacodynamic substances.Results:The average total flavonoid content in the leaves of the eight batches of P. hydropiper was 0.4 mg/mL, while the average total flavonoid content in the stems was 0.3 mg/mL. The average DPPH scavenging rate of the leaves in the eight batches of P. hydropiper was 99.35%, while the average DPPH scavenging rate of the stems was 98.88%. According to the results of the HPLC assay, the content of flavonoids is significantly higher in leaves than in stems. Kaempferol was not detected in stem samples from various batches. The highest percentage of terpenoids was found in the leaves by GC-MS assay.Conclusion:The medicinal components were concentrated in the leaves of P. hydropiper, which could contribute to cost savings, increase production efficiency, and promote the development of the P. hydropiper industry.

Zhongguo Yiyuan Yaoxue Zazhi

Bioequivalence of cefaclor granula in healthy male volunteers

Author: Li, Jin-feng ; Lin, Ming-qin ; Sha, Ying ; Wang, Jiu-hui ; Li, Pei-qiong

The bioequivalence of cefaclor granules in healthy male volunteers was evaluated.In a randomized crossover study, 20 healthy male volunteers were given a single oral dose of cefaclor.The serum concentrations of cefaclor before and after administration at different time points were determined by HPLC.The pharmacokinetic parameters were calculated and a statistical anal. using DAS 2.0 software program.The main pharmacokinetic parameters of reference and test preparation t_max, C_max, AUC_0→5 and AUC_0→∞ were (0.68±0.12) h and (0.68±0.12) h, (12.21±2.80) μg · ml^-1 and (11.70±2.65) μg · ml^-1, (14.33±3.12) μg · ml^-1 · h and (13.65±2.72) μg · ml^-1 · h, (14.58±3.20) μg · ml^-1 · h and (13.88±2.79) μg · ml^-1 · h.The statistical anal. showed that the main pharmacokinetic parameters between test and reference preparations were no significant differences.The 90% confidence interval of tested preparations C_max, AUC_0→5 and AUC_0→∞ were 88.3%-104.3%, 88.1%-104.6% and 90.1%-102.4%.The test and reference preparations were bioequivalent.

Zhongguo Yaoye

Human body bioequivalence of amoxicillin dispersible tablets

Author: Lin, Mingqin ; Wang, Jiuhui ; Li, Peiqiong ; Sha, Ying ; Li, Jinfeng

The plasma concentration of amoxicillin in healthy volunteers was determined and the human body bioequivalence of Amoxicillin Dispersible Tablets was evaluated.A single oral dose of tested and reference preparations was given to 20 healthy male volunteers in a randomized two-period cross-over design.The plasma concentrations of amoxicillin before and after administration at different time points were determined by RP-HPLC with UV detection.The pharmacokinetic parameters were calculated and analyzed using the DAS 2.0 software.The t_max, C_max, AUC_0-15 and AUC_0-∞ of the tested and reference preparations were (1.35±0.24) h and (1.30±0.25) h, (9.83±2.11) μg/mL and (10.03±1.93) μg/mL, (24.85±3.98) μg · h/mL and (25.10±4.41) μg · h/mL, (25.56±4.24) μg · h/mL and (25.81±4.48) μg · h/mL resp.The statistical anal. results showed that the main pharmacokinetic parameters had no statistically significant differences between the tested and reference preparationsThe 90% confidence interval of the tested preparations C_max, AUC_0-8 and AUC_0-∞ were 99.5%-105.7%, 97.4%-104.4% and 96.6%-105.5% resp.The tested and reference preparations are bioequivalent.

100 Deals associated with Haikou Pharmaceutical Factory Co., Ltd

100 Translational Medicine associated with Haikou Pharmaceutical Factory Co., Ltd

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