[Translation] A randomized, open-label, single-dose, two-dose, crossover design formal bioequivalence trial of vonoprazan fumarate tablets in Chinese healthy subjects

主要研究目的：以浙江核力欣健药业有限公司的富马酸伏诺拉生片为受试制剂，并以Takeda Pharmaceutical Company Limited的富马酸伏诺拉生片为参比制剂，进行人体生物等效性评价。

[Translation]

Main research purpose: To evaluate the bioequivalence of vonoprazan fumarate tablets produced by Zhejiang Helixinjian Pharmaceutical Co., Ltd. as the test preparation and vonoprazan fumarate tablets produced by Takeda Pharmaceutical Company Limited as the reference preparation in humans.

Start Date16 Jun 2023

Sponsor / Collaborator

Zhejiang Helixinjian Pharmaceutcal Co., Ltd.

CTR20222277 / CompletedNot Applicable

替普瑞酮胶囊在中国健康受试者的单中心、随机、开放的生物等效性试验

[Translation] A single-center, randomized, open-label bioequivalence trial of teprenone capsules in healthy Chinese subjects

主要目的：本试验旨在研究单次空腹口服受试制剂的药代动力学特征，比较受试制剂与参比制剂中药动学参数Cmax、AUC0-t、AUC0-∞，评价两制剂在健康受试者中的生物等效性。次要目的：观察受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

Primary purpose: This study aims to study the pharmacokinetic characteristics of the test preparation after a single oral fasting dose, compare the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ between the test preparation and the reference preparation, and evaluate the bioequivalence of the two preparations in healthy subjects. Secondary purpose: Observe the safety of the test preparation and the reference preparation in healthy subjects.

Start Date06 Sep 2022

Sponsor / Collaborator

Zhejiang Helixinjian Pharmaceutcal Co., Ltd.

CTR20221377 / CompletedNot Applicable

Y-001在中国健康受试者空腹状态下单中心、随机、开放、双周期、双交叉设计的生物等效性试验

[Translation] A single-center, randomized, open-label, two-period, double-crossover bioequivalence study of Y-001 in Chinese healthy subjects under fasting condition

主要目的：评价Y-001与参比制剂在健康成年受试者空腹状态下单次口服给药的人体生物等效性。次要目的：评价Y-001在健康成年受试者中的安全性。

[Translation]

Primary objective: To evaluate the bioequivalence of Y-001 and the reference formulation in healthy adult subjects after a single oral administration in the fasting state. Secondary objective: To evaluate the safety of Y-001 in healthy adult subjects.

Start Date07 Jun 2022

Sponsor / Collaborator

Zhejiang Helixinjian Pharmaceutcal Co., Ltd.

100 Clinical Results associated with Zhejiang Helixinjian Pharmaceutcal Co., Ltd.

0 Patents (Medical) associated with Zhejiang Helixinjian Pharmaceutcal Co., Ltd.

Literatures (Medical) associated with Zhejiang Helixinjian Pharmaceutcal Co., Ltd.

Zhongguo Yaoye

Determination of the Residual Organic Solvents in Synthetic Intermediate Materials of Rosuvastatin Calcium by Headspace Gas Chromatography

Author: Si Zhiping ; Xu Shifang

Objective To establish a headspace gas chromatog. method for the determination of acetaldehyde, ethanol, di-Me sulfide and toluene in the synthetic intermediate materials( 4 R-cis)-6-aldehyde-2, 2-dimethyl-1, 3-dioxane-4-Bu acetate of rosuvastatin calcium.Methods Gas chromatog.( GC) was performed with Rtx-624 capillary column( 60 m x 0. 25 mm, 1. 4 μm) with6% cyanopropylphenyl-94% dimethylpolysiloxane as stationary phase and programmed heating, the detector was flame ionization detector( FID) with temperature of 250 °C, the temperature of injection port was 200 °C, the split ratio was 30 : 1, the carrier gas was nitrogen, the equilibrium temperature of headspace bottle was 90 °C, the equilibrium time of headspace bottle was 30 min, the temperature of quant. loop was 120 °C, the temperature of transmission line was 130 °C, and the injection volume was 1 m L.GCMS solution 2. 71 workstation was adopted with electron bombardment( ESI) ion source, the temperature of ion source was 230 °C, the temperature of transmission line was 250 °C, and the mass scanning range m/z was 45-550.Results Acetaldehyde, ethanol, di-Me sulfide and toluene were completely separated from the adjacent peaks, and their linear ranges were 80. 04-800. 36 μg/m L, 103. 94-1 039. 44 μg/m L, 19. 27-192. 68 μg/m L, 17. 97-179. 72 μg/m L( R2> 0. 995), resp.The average recoveries of acetaldehyde, ethanol, di-Me sulfide and toluene were 92. 73%, 91. 75%, 88. 45%, 86. 89% with RSDs of 2. 33%, 3. 19%, 2. 57%, 3. 62%( n = 9), resp.Conclusion The method is simple, accurate and sensitive, which can be used for the determination of residual organic solvents in the synthetic intermediate materials of rosuvastatin calcium and provide a reference for the quality control of the materials.

100 Deals associated with Zhejiang Helixinjian Pharmaceutcal Co., Ltd.

100 Translational Medicine associated with Zhejiang Helixinjian Pharmaceutcal Co., Ltd.

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