[Translation] A randomized, open-label, two-dose, single-dose, two-period, double-crossover bioequivalence study of chloral hydrate suppositories in healthy subjects under fasting conditions

评价中国健康受试者在空腹状态下单次直肠给予受试制剂水合氯醛栓（规格：250 mg，山东达因海洋生物制药股份有限公司生产）与参比制剂水合氯醛栓（ESCRE，规格：250 mg，日本久光制药株式会社生产）的药代动力学特征，比较两种制剂的人体相对生物利用度，评价空腹状态直肠给予两种制剂的生物等效性。观察水合氯醛栓受试制剂和参比制剂在健康人群中的安全性。

[Translation]

To evaluate the pharmacokinetic characteristics of the test preparation chloral hydrate suppository (specification: 250 mg, produced by Shandong Dayin Marine Biopharmaceutical Co., Ltd.) and the reference preparation chloral hydrate suppository (ESCRE, specification: 250 mg, produced by Hisamitsu Pharmaceutical Co., Ltd., Japan) in Chinese healthy subjects after single rectal administration in the fasting state, compare the relative bioavailability of the two preparations in humans, and evaluate the bioequivalence of the two preparations after rectal administration in the fasting state. To observe the safety of the test preparation and reference preparation of chloral hydrate suppository in healthy people.

Start Date03 Sep 2024

Sponsor / Collaborator

Shandong Dayin Oceanic Biochemicals Co. Ltd.

CTR20240123 / CompletedNot Applicable

艾司奥美拉唑镁肠溶干混悬剂生物等效性试验

[Translation] Bioequivalence study of esomeprazole magnesium enteric-coated dry suspension

主要目的：比较两种制剂(受试制剂和参比制剂)在空腹和餐后条件下单次给药的生物等效性。次要目的：评估单剂口服受试制剂和参比制剂在中国健康成年受试者中的安全性。

[Translation]

Primary objective: To compare the bioequivalence of two formulations (test formulation and reference formulation) after single administration under fasting and fed conditions. Secondary objective: To evaluate the safety of single oral doses of test formulation and reference formulation in healthy Chinese adult subjects.

Start Date05 Mar 2024

Sponsor / Collaborator

Shandong Dayin Oceanic Biochemicals Co. Ltd.

CTR20233150 / CompletedNot Applicable

水合氯醛栓在男性健康受试者中随机、开放、两制剂、单次给药、双周期、双交叉空腹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 chloral hydrate suppositories in healthy male subjects under fasting conditions

评价中国男性健康受试者在空腹状态下单次直肠给予受试制剂水合氯醛栓（规格：250 mg，山东达因海洋生物制药股份有限公司生产）与参比制剂水合氯醛栓（ESCRE？，规格：250 mg，日本久光制药株式会社生产）的药代动力学特征，比较两种制剂的人体相对生物利用度，评价空腹状态分别直肠给药两种制剂的生物等效性。观察水合氯醛栓受试制剂和参比制剂在健康人群中的安全性。

[Translation]

To evaluate the pharmacokinetic characteristics of the test preparation chloral hydrate suppository (specification: 250 mg, produced by Shandong Dayin Marine Biopharmaceutical Co., Ltd.) and the reference preparation chloral hydrate suppository (ESCRE?, specification: 250 mg, produced by Hisamitsu Pharmaceutical Co., Ltd., Japan) in Chinese healthy male subjects after single rectal administration in the fasting state, compare the relative bioavailability of the two preparations in humans, and evaluate the bioequivalence of the two preparations after rectal administration in the fasting state. To observe the safety of the test preparation and reference preparation of chloral hydrate suppository in healthy people.

Start Date06 Nov 2023

Sponsor / Collaborator

Shandong Dayin Oceanic Biochemicals Co. Ltd.

100 Clinical Results associated with Shandong Dayin Oceanic Biochemicals Co. Ltd.

0 Patents (Medical) associated with Shandong Dayin Oceanic Biochemicals Co. Ltd.

Literatures (Medical) associated with Shandong Dayin Oceanic Biochemicals Co. Ltd.

01 Jan 2023·Carbohydrate Polymers

Preparation of pectin-chitosan hydrogels based on bioadhesive-design micelle to prompt bacterial infection wound healing

Article

Author: Zhang, Xiuli ; Wen, Jin ; Liu, Yi ; Song, Kaichao ; He, Shuwang ; Wang, Lulu ; Hao, Yumei ; Cao, Ruifeng ; Zheng, Wensheng ; Zhang, Yujia

The aim of this study was to design a pectin-chitosan (PEC-CS) hydrogel loaded with a bioadhesive-design micelle containing large amount of ciprofloxacin for antibacterial and healing wound applications. Pectin and chitosan are crosslinked in a safe and convenient way, and the PEC-CS hydrogel have high water content (>95 %), strong water absorption (15,000 %), good water retention (>10,000 % at 30 % RH for 12 h), and the PEC-CS hydrogels showed no cytotoxicity and hemolysis, thus providing a humid microenvironment suitable for wound. Additionally, the dopamine modified carrier can greatly improve the solubility and retention time in the wound of ciprofloxacin, effectively increase the efficiency of drug loading into the PEC-CS hydrogels and exert antibacterial activity in the wound for a long time. In vitro and in vivo pharmacodynamics experiments have shown that PEC-CS#CIP@DPDMCs hydrogels can resist bacteria and promote wound healing. Thus，The PEC-CS#CIP@DPDMCs hydrogels can be a potential anti-infective hydrogel excipient.

01 Sep 2019·Synthesis

Copper-Catalyzed Deoxygenative C2-Sulfonylation of Quinoline N-Oxides with DABSO and Phenyldiazonium Tetrafluoroborates for the Synthesis of 2-Sulfonylquinolines via a Radical Reaction

Author: Yan, Shi-Qiang ; Wang, Zu-Li ; Dong, Dao-Qing ; Deng, Qi ; Li, Guang-Hui

An efficient and practical method for the synthesis of 2-sulfonylquinolines through copper-catalyzed deoxygenative C2-sulfonylation of quinoline N-oxides with 1,4-diazabicyclo[2.2.2]octane bis(sulfur dioxide) (DABSO) and phenyldiazonium tetrafluoroborates is demonstrated. Products with various substituents were obtained in moderate to high yields.

01 Jul 2017·Zhongguo Zhong yao za zhi = Zhongguo zhongyao zazhi = China journal of Chinese materia medica

[In vivo transdermal penetration enhancing activity of essential oil from Zanthoxyli Pericarpium by using microdialysis technique].

Article

Author: Xie, Xuan ; Shi, Da-Yong ; Wu, Qing ; Lan, Yi ; Wu, Xue-Ping ; Yang, Lin ; Wang, Ying-Xin

The aim of this paper is to investigate the topical pharmacodynamics behavior of different lipophilic model drugs after treatment with essential oil from Zanthoxyli Pericarpium by using the cutaneous microdialysis technique, and then evaluate its in vivo transdermal penetration enhancing properties. Two traditional Chinese medicine active components, namely tetramethylpyrazine and puerarin, were chosen as lipophilic and hydrophilic model drugs, respectively. Firstly, the concentration difference method was employed to measure the in vitro recovery rate and loss of the microdialysis probe, and the in vivo recoveries of two model drugs were determined by using the retrodialysis method. Secondly, the skin pharmacodynamics behaviors of two model drugs were studied after treatment with different concentrations of the essential oil, and the well-established and standard penetration enhancer Azone was selected as a positive control. It was found that the recovery of microdialysis probe was equal to its loss for two model drugs, with no interaction between drugs in dialysis membranes. The retrodialysis studies revealed that the in vivo recovery of tetramethylpyrazine and puerarin were 59.17%, 19.85%, respectively. The skin pharmacodynamics studies showed that the essential oil could facilitate the transdermal absorption of tetramethylpyrazine in a concentration-dependent manner, and the enhancement ratio (ER) for 5% essential oil was 98.64, which was higher than that of the optimum concentration of Azone (3% Azone, ER=89.11). Meanwhile, the Zanthoxyli Pericarpium could effectively promote the transdermal permeation of the puerarin in a concentration-dependent manner. Hence, this study further confirmed that the Zanthoxyli Pericarpium had excellent penetration-enhancing activity as a natural transdermal penetration enhancer, providing data support for its application in traditional Chinese medicine external preparations.

100 Deals associated with Shandong Dayin Oceanic Biochemicals Co. Ltd.

100 Translational Medicine associated with Shandong Dayin Oceanic Biochemicals Co. Ltd.

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