研究健康研究参与者在餐后状态下，单次口服由华润双鹤药业股份有限公司提供的巴瑞替尼片（受试制剂T，规格：2mg）与单次口服由Eli Lilly Nederland B.V.持证的巴瑞替尼片（参比制剂R，商品名：Olumiant®，规格：2mg）的药动学特征，比较两制剂间药动学参数AUC和Cmax的差异，初步评估两制剂生物等效性。

[Translation]

To investigate the pharmacokinetic characteristics of a single oral dose of baricitinib tablets (test preparation T, strength: 2 mg) provided by China Resources Double Crane Pharmaceutical Co., Ltd. and a single oral dose of baricitinib tablets (reference preparation R, trade name: Olumiant®, strength: 2 mg) certified by Eli Lilly Nederland B.V. in healthy study participants in the postprandial state, to compare the differences in pharmacokinetic parameters AUC and Cmax between the two preparations, and to preliminarily evaluate the bioequivalence of the two preparations.

Start Date25 Aug 2024

Sponsor / Collaborator

Beijing Wanhui Double-Crane Pharmaceutical Co. Ltd.

CTR20242779 / Active, not recruitingNot Applicable

盐酸吡格列酮分散片人体生物等效性试验

[Translation] Bioequivalence study of pioglitazone hydrochloride dispersible tablets in human body

主要目的：采用单中心、随机、开放、两制剂、两周期交叉、单剂量、空腹及餐后给药设计，比较空腹及餐后给药条件下，贵州天安药业股份有限公司提供的盐酸吡格列酮分散片（规格：30 mg）与武田テバ薬品株式会社持证的盐酸吡格列酮片（商品名：ACTOS®，规格：30 mg）在中国健康人群中吸收程度和吸收速度的差异。次要目的：评价空腹及餐后条件下，贵州天安药业股份有限公司提供的盐酸吡格列酮分散片（规格：30 mg）与武田テバ薬品株式会社持证的盐酸吡格列酮片（商品名：ACTOS®，规格：30 mg）的安全性。

[Translation]

Primary objective: To compare the differences in absorption degree and absorption rate between pioglitazone hydrochloride dispersible tablets (specification: 30 mg) provided by Guizhou Tianan Pharmaceutical Co., Ltd. and pioglitazone hydrochloride tablets (trade name: ACTOS®, specification: 30 mg) certified by Takeda Teba Pharmaceutical Co., Ltd. in healthy Chinese population under fasting and postprandial administration conditions using a single-center, randomized, open, two-dose, two-period crossover, single-dose, fasting and postprandial administration design. Secondary objective: To evaluate the safety of pioglitazone hydrochloride dispersible tablets (specification: 30 mg) provided by Guizhou Tianan Pharmaceutical Co., Ltd. and pioglitazone hydrochloride tablets (trade name: ACTOS®, specification: 30 mg) certified by Takeda Teba Pharmaceutical Co., Ltd. under fasting and postprandial conditions.

Start Date23 Aug 2024

Sponsor / Collaborator

Guizhou Tian'an Pharmaceutical Co. Ltd.

CTR20241708 / CompletedNot Applicable

健康成年受试者空腹和餐后状态下单次口服尼麦角林片的随机、开放、单剂量、四周期、完全重复交叉设计的生物等效性试验

[Translation] A randomized, open-label, single-dose, four-period, completely repeated crossover bioequivalence study of a single oral dose of nicergoline tablets in healthy adult subjects in the fasting and fed state

主要研究目的：研究空腹和餐后状态下单次口服受试制剂尼麦角林片（规格：30mg，华润双鹤利民药业（济南）有限公司生产）与参比制剂尼麦角林片（Sermion®，规格：30mg，Pfizer Italia S.r.l.生产）在健康成年受试者体内的药代动力学，评价空腹和餐后状态口服两种制剂的生物等效性。次要研究目的：评价健康受试者在空腹和餐后状态下，单次口服尼麦角林片受试制剂和参比制剂后的安全性。

[Translation]

The main purpose of the study is to study the pharmacokinetics of the test preparation Nicergoline Tablets (Specification: 30mg, produced by China Resources Double Crane Limin Pharmaceutical (Jinan) Co., Ltd.) and the reference preparation Nicergoline Tablets (Sermion®, Specification: 30mg, produced by Pfizer Italia S.r.l.) in healthy adult subjects after a single oral administration in the fasting and fed state, and to evaluate the bioequivalence of the two preparations after oral administration in the fasting and fed state. Secondary purpose of the study is to evaluate the safety of the test preparation and reference preparation of Nicergoline Tablets after a single oral administration in healthy subjects in the fasting and fed state.

Start Date22 Jun 2024

Sponsor / Collaborator

China Resources Double-Crane Pharmaceutical (Jinan) Co., Ltd.

100 Clinical Results associated with China Resources Double-Crane Pharmaceutical Co., Ltd.

0 Patents (Medical) associated with China Resources Double-Crane Pharmaceutical Co., Ltd.

Literatures (Medical) associated with China Resources Double-Crane Pharmaceutical Co., Ltd.

01 Sep 2023·Journal of cosmetic dermatology

Synergy of GHK-Cu and hyaluronic acid on collagen IV upregulation via fibroblast and ex-vivo skin tests.

Article

Author: Huang, Yi ; Hong, Minhua ; Wu, Yanan ; Jiang, Fangru ; Liu, Zhe

INTRODUCTIONGHK-Cu and HA are two commonly used skin care ingredients, both of which were reported to enhance collagen synthesis. This work aims to investigate their co-effect on collagen regulation.MATERIALS AND METHODSIn cell experiments, human dermal fibroblasts were treated by a series of GHK-Cu and HA combinations, and the expressions of collagen I, IV, and VII were measured by qRT-PCR. The best formula screened out from cell experiments were further studied by ex-vivo skin model, and the content of collagen IV was quantified by immunofluorescence method.RESULTSThe combination GHK-Cu and HA was found to promote the generation of collagen I, IV, and VII. Especially, they form a synergy on collagen IV. At the ratio of 1:9, GHK-Cu and LMW HA deliver the strongest effect to elevate collagen IV synthesis by 25.4 times in cell test and 2.03 times in ex-vivo skin test.CONCLUSIONThe co-effect of GHK-Cu and HA was revealed. Their synergy brings an insight to anti-aging technology: choosing proper molecular weight of HA and managing its ratio with GHK-Cu could enhance DEJ health via stimulating collagen IV synthesis.

01 Dec 2021·Journal of NanobiotechnologyQ2 · ENGINEERING & TECHNOLOGY

Research on the fate of polymeric nanoparticles in the process of the intestinal absorption based on model nanoparticles with various characteristics: size, surface charge and pro-hydrophobics

Q2 · ENGINEERING & TECHNOLOGY

ArticleOA

Author: Li, Youxin ; Shi, Yanan ; Guo, Shiqi ; Liu, Lanze ; Sun, Kaoxiang ; Yin, Miaomiao ; Liang, Yanzi ; Wang, Aiping

AbstractBackgroundThe use of drug nanocarriers to encapsulate drugs for oral administration may become an important strategy in addressing the challenging oral absorption of some drugs. In this study—with the premise of controlling single variables—we prepared model nanoparticles with different particle sizes, surface charges, and surface hydrophobicity/hydrophilicity. The two key stages of intestinal nanoparticles (NPs) absorption—the intestinal mucus layer penetration stage and the trans-intestinal epithelial cell stage—were decoupled and analyzed. The intestinal absorption of each group of model NPs was then investigated.ResultsDifferences in the behavioral trends of NPs in each stage of intestinal absorption were found to result from differences in particle properties. Small size, low-magnitude negative charge, and moderate hydrophilicity helped NPs pass through the small intestinal mucus layer more easily. Once through the mucus layer, an appropriate size, positive surface charge, and hydrophobic properties helped NPs complete the process of transintestinal epithelial cell transport.ConclusionsTo achieve high drug bioavailability, the basic properties of the delivery system must be suitable for overcoming the physiological barrier of the gastrointestinal tract.

01 Aug 2020·Food Science and BiotechnologyQ3 · AGRICULTURAL & FORESTRY SCIENCE

A quick, accurate and general ultra performance liquid chromatography method for evaluating the quality of enological tannins

Q3 · AGRICULTURAL & FORESTRY SCIENCE

Article

Author: Yu, Wei Chao ; Sun, Bao Shan ; Li, Zhe ; Cui, Yan

Commercial enological tannins from various origins have been widely used in modern wine making. In order to investigate the diverse quality of tannin products, a quick, accurate and simple UPLC method was developed, which could simultaneously determine 11 principle characteristic components of hydrolysable tannins and condensed tannins. The optimum resolution of the tannins was achieved on a Waters Acquity UPLC-BEH C18 column (2.1 mm × 50 mm, 1.7 μm) at 280 nm with gradient elution. The method was validated to achieve desired specificity, linearity, precision, accuracy and stability. The developed method was successfully applied to 30 commercial enological tannins from different origins for their quality evaluation. The 30 tannin samples were qualitatively distinguished into hydrolysable, condensed or mixture tannins, and quantificationally classified into four levels of excellent, good, fair and poor products. The method could be used for quick evaluating the quality of enological tannins in practical use.

News (Medical) associated with China Resources Double-Crane Pharmaceutical Co., Ltd.

05 Jan 2024

·www.globenewswire.com

LifeScience Logistics Expands Raleigh-Durham Presence with Second Pharmaceutical Storage and Distribution Facility for Pharmaceutical and Medical Device Manufacturers

New 249,600 SF Raleigh-Durham location slated to launch by end of Q1 2024, marking expanded offerings for pharmaceutical and medical device manufacturers seeking a comprehensive pharmaceutical storage and distribution partnerDALLAS, Jan. 05, 2024 (GLOBE NEWSWIRE) -- LifeScience Logistics (LSL), a leading provider of healthcare supply chain solutions since 2006, announced that construction of its newest facility will be completed in early 2024. This facility will be LSL’s 17th strategic location across the United States and the second location added to the Raleigh-Durham hub. This innovative 249,600 SF facility, located in the heart of Research Triangle Park, will expand LSL’s capacity to provide FDA-registered, cGMP-compliant, temperature-controlled storage and end-to-end 3PL solutions to pharmaceutical and medical device manufacturers operating in the Raleigh-Durham area. “Within six months of opening our latest Research Triangle Park warehouse, demand exceeded our existing capacity. This indicated to us that there was a massive need for cGMP-compliant, temperature-controlled storage space in North Carolina,” said John Blackington, Vice President of Business Development at LifeScience Logistics. “We decided to build an additional facility to support the unprecedented demand for both pharmaceutical and medical device temperature-controlled storage and distribution in the Raleigh-Durham region.” LSL anticipates strong demand for the solutions offered in their latest Raleigh-Durham facility. The new location will ensure the safe and compliant storage of finished goods, API, raw materials, and packaging materials. This facility will also offer value-added services such as kitting, relabeling, repalletization, and tailgate sampling through the highly secure, fully licensed warehouse. The new site brings LSL’s total storage footprint to over 5.7M SF across 11 states. About LifeScience Logistics Founded in 2006, DFW-based LifeScience Logistics (LSL) is a leading, national provider of end-to-end, high-quality, customizable healthcare supply chain solutions. For clients ranging from Fortune 500 companies to startups, LSL offers its pharmaceutical, medical device, and biotech clients the ability to outsource services ranging from distribution to kitting to back- and middle-office functions. FDA-registered and NABP-accredited, LSL operates from 17 locations across 11 states totaling more than 5.7 million SF of cGMP compliant space. Contact:Hope Husbyhhusby@lslog.com

100 Deals associated with China Resources Double-Crane Pharmaceutical Co., Ltd.

100 Translational Medicine associated with China Resources Double-Crane Pharmaceutical Co., Ltd.

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The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Drug(Targets)	Indications	Global Highest Phase

Hydrochlorothiazide/Triamterene/Dihydralazine Sulfate/Reserpine ( NCC x Sodium channels x VMAT2 )	Hypertension More	Approved
Bromisoval	Anxiety Disorders More	Approved
Hydroxocobalamin ( IFNAR )	Vitamin B 12 Deficiency More	Approved
Gestrinone ( PR )	Endometriosis More	Approved
Levobunolol Hydrochloride ( β-adrenoceptors )	Glaucoma More	Approved

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