[Translation] A randomized, open-label, two-dose, three-period, partially repeated crossover, postprandial bioequivalence study of amoxicillin-clavulanate potassium dry suspension (7:1) in healthy volunteers

主要目的：以山东益康药业股份有限公司生产的阿莫西林克拉维酸钾干混悬剂（7:1）规格：0.457g（C16H19N3O5S 0.40g与C8H9NO5 0.057g）为受试制剂，以英国SmithKline Beecham Ltd生产的原研药品Amoxicillin and Clavulanate Potassium for Suspension/Augmentin Duo 400mg/57 mg为参比制剂，比较健康受试者在餐后状态下，单次口服受试制剂或参比制剂后的相对生物利用度，评价受试制剂与参比制剂间的生物等效性。次要目的：通过不良事件发生率、实验室检验结果、生命体征和体格检查等的变化情况观察受试制剂和参比制剂在中国健康受试者中的安全性和耐受性。

[Translation]

Primary objective: To compare the relative bioavailability of the test preparation or the reference preparation after a single oral administration of the test preparation or the reference preparation in healthy subjects in the postprandial state using amoxicillin and clavulanate potassium dry suspension (7:1) with a specification of 0.457 g (C16H19N3O5S 0.40 g and C8H9NO5 0.057 g) produced by Shandong Yikang Pharmaceutical Co., Ltd. as the test preparation and the original drug Amoxicillin and Clavulanate Potassium for Suspension/Augmentin Duo 400 mg/57 mg produced by SmithKline Beecham Ltd in the UK as the reference preparation, and to evaluate the bioequivalence between the test preparation and the reference preparation. Secondary objective: To observe the safety and tolerability of the test preparation and the reference preparation in healthy Chinese subjects through the changes in the incidence of adverse events, laboratory test results, vital signs and physical examinations.

Start Date24 Mar 2024

Sponsor / Collaborator

Shandong Yikang Pharmaceutical Co. Ltd.

CTR20233346 / CompletedNot Applicable

恩格列净片随机、开放、两制剂、两周期、交叉、健康人体空腹和餐后生物等效性试验。

[Translation] A randomized, open-label, two-dose, two-period, crossover bioequivalence study of empagliflozin tablets in healthy volunteers on a fasting and fed diet.

研究健康受试者在空腹/餐后状态下，单次口服由山东益康药业股份有限公司生产的恩格列净片25mg（受试制剂）和勃林格殷格翰药业有限公司（Boehringer Ingelheim Pharma GmbH & Co.KG）生产的原研恩格列净片25mg（Jardiance®/欧唐静®，参比制剂）的相对生物利用度，评价受试制剂与参比制剂的生物等效性。

[Translation]

To study the relative bioavailability of a single oral dose of 25 mg empagliflozin tablets produced by Shandong Yikang Pharmaceutical Co., Ltd. (test preparation) and 25 mg empagliflozin tablets (Jardiance®/Otangjing®, reference preparation) produced by Boehringer Ingelheim Pharma GmbH & Co.KG in healthy subjects under fasting/postprandial conditions, and to evaluate the bioequivalence of the test preparation and the reference preparation.

Start Date21 Nov 2023

Sponsor / Collaborator

Shandong Yikang Pharmaceutical Co. Ltd.

CTR20222316 / CompletedNot Applicable

评估受试制剂山东益康药业奥美拉唑碳酸氢钠干混悬剂（Ⅰ）20mg/1680mg与参比制剂Salix奥美拉唑碳酸氢钠干混悬剂20mg/1680mg作用于健康成年受试者在空腹状态下的单中心、开放、随机、单剂量、两周期、两序列、交叉生物等效性研究

[Translation] A single-center, open, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study to evaluate the test preparation Shandong Yikang Pharmaceutical Omeprazole Sodium Bicarbonate Dry Suspension (I) 20mg/1680mg and the reference preparation Salix Omeprazole Sodium Bicarbonate Dry Suspension 20mg/1680mg in healthy adult subjects in the fasting state

主要研究目的：研究空腹状态下单次口服受试制剂奥美拉唑碳酸氢钠干混悬剂（Ⅰ）（规格：每袋含奥美拉唑20mg与碳酸氢钠1680mg，山东益康药业股份有限公司生产）与参比制剂奥美拉唑碳酸氢钠干混悬剂（商品名ZEGERID，规格：每袋含奥美拉唑20mg与碳酸氢钠1680mg；Salix Pharmaceuticals Inc产品）在健康受试者体内的药代动力学，评价空腹状态口服两种制剂的生物等效性。次要研究目的：研究受试制剂参比制剂在健康受试者中的安全性。

[Translation]

The main purpose of the study is to study the pharmacokinetics of the test preparation omeprazole sodium bicarbonate dry suspension (Ⅰ) (specification: each bag contains 20 mg omeprazole and 1680 mg sodium bicarbonate, produced by Shandong Yikang Pharmaceutical Co., Ltd.) and the reference preparation omeprazole sodium bicarbonate dry suspension (trade name ZEGERID, specification: each bag contains 20 mg omeprazole and 1680 mg sodium bicarbonate; product of Salix Pharmaceuticals Inc) in healthy subjects after a single oral administration in the fasting state, and to evaluate the bioequivalence of the two preparations taken orally in the fasting state. Secondary purpose of the study: to study the safety of the test preparation and the reference preparation in healthy subjects.

Start Date11 Aug 2022

Sponsor / Collaborator

Shandong Yikang Pharmaceutical Co. Ltd.

100 Clinical Results associated with Shandong Yikang Pharmaceutical Co. Ltd.

0 Patents (Medical) associated with Shandong Yikang Pharmaceutical Co. Ltd.

Literatures (Medical) associated with Shandong Yikang Pharmaceutical Co. Ltd.

06 Dec 2023·Crystal Growth & Design

Characterization, Analysis, and Theoretical Calculation Studies of Solvates and Cocrystals of Betulin: An Exploration of the Boundary between Solvates and Cocrystals

Author: Wang, Yeyang ; Lu, Yang ; Zhang, Baoxi ; Du, Guanhua ; Li, Shuang ; An, Qi ; Wang, Wenwen ; Zhang, Li ; Zhou, Jian ; Hu, Kun ; Yuan, Penghui ; Yang, Dezhi

Cocrystals, as an excellent solid state to improve the physicochem. properties of active pharmaceutical ingredients, have always been discussed together with solvates since the definition of cocrystals was proposed.However, investigation and discussion of the boundary between cocrystals and solvates have not been common.In this work, aiming at betulin (BE)-a natural product with multiple pharmacol. activities, we designed its polymorphism and cocrystal screening experiments with different liquid organic solvents and solid cocrystal coformers (CCFs) that possess low and high m.ps., resp.Afterward, a hemihydrate, a new solvate with benzyl alc., and two new cocrystals of BE with phenol (PHE), and 3-hydroxybenzoic acid (3-HBA) resp., including their single crystal structures, were designed, prepared, and characterized by single-crystal X-ray diffraction, powder X-ray diffraction, and other solid-state anal. methods.A special thermal property for pharmaceutical cocrystals was found in cocrystal BE-PHE, i.e., it possesses an exact CCF loss process, which is different from cocrystal BE-3-HBA but is similar to the solvate of BE.To explain this phenomenon, theor. calculation studies were performed by mol. electrostatic potential surface anal., electron d. difference anal., energy decomposition anal., and energy framework anal. to realize an in-depth study of the sites, quantities, and energy of the intermol. interactions between BE and different coformer mols.Results indicated that the fewer interaction sites and the small interaction energy between BE and PHE mols. are the possible reasons for the unusual thermal properties of cocrystal BE-PHE.This finding also proved that the structural features of cocrystals can affect their physicochem. properties greatly.

Scientific ReportsQ3 · CROSS-FIELD

The cardioprotective effects of the new crystal form of puerarin in isoproterenol-induced myocardial ischemia rats based on metabolomics

Q3 · CROSS-FIELD

ArticleOA

Author: Gao, Zhaolin ; Qin, Xuemei ; Lv, Yang ; Song, Jia ; Shi, Yongqiang ; Du, Guanhua ; Li, Mengru ; Zhou, Yuzhi

AbstractPuerarin has shown unique pharmacological effects on myocardial ischemia (MI). Changing the crystal form is an effective approach to improve the cardioprotective effects of puerarin. However, the mechanisms of the new crystal form of puerarin are unclear. In this study, an electrocardiogram, echocardiography, cardiac marker enzymatic activity, oxidative stress indices, and myocardial histology analysis of cardiac tissues were performed to evaluate the cardioprotective effects of the new crystal form of puerarin. Moreover, serum and cardiac tissue metabolomics based on nuclear magnetic resonance (NMR) were used to investigate the potential mechanism of the new crystal form. The results indicated that the new crystal form of puerarin (30 mg/kg) could improve oxidative stress indices, and these improvements were similar to those of the original crystal form of puerarin (120 mg/kg). The new crystal form of puerarin (30 mg/kg) could effectively improve the activities of cardiac marker enzymes, and the improvement effects were better than those of the original crystal form (120 mg/kg). Moreover, metabolomics analysis showed that amino acid metabolism, oxidative stress and energy metabolism were disturbed after MI and could be improved by puerarin. These results demonstrated that the new crystal form of puerarin was effective in treating MI.

100 Deals associated with Shandong Yikang Pharmaceutical Co. Ltd.

100 Translational Medicine associated with Shandong Yikang Pharmaceutical Co. Ltd.

Corporation Tree

Boost your research with our corporation tree data.

view full example data

Pipeline

Pipeline Snapshot as of 26 Nov 2024

No data posted

Deal

Boost your decision using our deal data.

view full example data

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Profit

Explore the financial positions of over 360K organizations with Synapse.

view full example data

Grant & Funding(NIH)

Access more than 2 million grant and funding information to elevate your research journey.

view full example data

Investment

Gain insights on the latest company investments from start-ups to established corporations.

view full example data

Financing

Unearth financing trends to validate and advance investment opportunities.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis

Shandong Yikang Pharmaceutical Co. Ltd.

Overview

Related

Corporation Tree

Pipeline

Pipeline Snapshot as of 26 Nov 2024

Deal

Translational Medicine

Profit

Grant & Funding(NIH)

Investment

Financing