本试验旨在研究单次空腹和餐后口服重庆莱美药业股份有限公司研制、生产的尼可地尔片（5 mg）的药代动力学特征；以Nipro Pharma Corporation Kagamiishi Plant生产的尼可地尔片（喜格迈®，5 mg）为参比制剂，比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞，评价两制剂的人体生物等效性。

[Translation]

The aim of this study was to investigate the pharmacokinetic characteristics of nicorandil tablets (5 mg) developed and produced by Chongqing Laimi Pharmaceutical Co., Ltd. after single oral administration on an empty stomach or after a meal. Nicorandil tablets (Xigemai®, 5 mg) produced by Nipro Pharma Corporation Kagamiishi Plant was used as the reference preparation. The pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared to evaluate the bioequivalence of the two preparations in humans.

Start Date21 Jan 2024

Sponsor / Collaborator

Chongqing Lummy Pharmaceutical Co., Ltd.

CTR20232106 / CompletedNot Applicable

阿奇霉素颗粒在中国健康受试者中单中心、随机、开放、单剂量、两制剂、两周期、两序列、双交叉空腹/餐后状态下生物等效性试验

[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-period, two-sequence, double-crossover bioequivalence study of azithromycin granules in Chinese healthy subjects under fasting/fed conditions

主要目的：健康受试者空腹或餐后状态下，单次口服重庆莱美药业股份有限公司生产的受试制剂阿奇霉素颗粒（规格：100mg/袋）或ファイザー株式会社（辉瑞）生产的参比制剂小儿用阿奇霉素细粒剂10%（商品名：希舒美®；规格：100mg:1g），分别考察空腹或餐后状态下受试制剂与参比制剂在健康受试者体内的药代动力学参数，评价两制剂的生物等效性。次要目的：考察受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

Primary objective: To examine the pharmacokinetic parameters of the test preparation and the reference preparation in the fasting or postprandial state in healthy subjects by taking a single oral dose of the test preparation azithromycin granules (specification: 100 mg/bag) produced by Chongqing Laimi Pharmaceutical Co., Ltd. or the reference preparation azithromycin fine granules 10% for children (trade name: Xishumei®; specification: 100 mg: 1g) produced by Pfizer Co., Ltd., and evaluate the bioequivalence of the two preparations. Secondary objective: To examine the safety of the test preparation and the reference preparation in healthy subjects.

Start Date10 Aug 2023

Sponsor / Collaborator

Chongqing Lummy Pharmaceutical Co., Ltd.

CTR20222235 / RecruitingPhase 1

一项评估纳米炭铁混悬注射液（CNSI-Fe）瘤内注射在晚期实体瘤患者中的安全性、耐受性、药代动力学（PK）特征和初步疗效的I期临床研究

[Translation] A Phase I clinical study to evaluate the safety, tolerability, pharmacokinetic (PK) characteristics and preliminary efficacy of intratumoral injection of carbon nano-iron suspension injection (CNSI-Fe) in patients with advanced solid tumors

主要目的：评估瘤内注射不同剂量的纳米炭铁混悬注射液（CNSI-Fe）在晚期实体瘤患者中的安全性和耐受性，并观察CNSI-Fe的剂量限制性毒性（DLT），确定在人体的最大耐受剂量（MTD）或最高注射剂量，为后续临床研究提供剂量选择依据。次要目的：评估瘤内注射不同剂量的CNSI-Fe在晚期实体瘤患者中的药代动力学（PK）特征；初步评估瘤内注射不同剂量的CNSI-Fe在晚期实体瘤患者中的疗效。探索性目的：评估瘤内注射不同剂量的CNSI-Fe在晚期实体瘤患者中的瘤内药效动力学（PD）特征（不作强制要求）；评估瘤内注射不同剂量的CNSI-Fe在晚期实体瘤患者中的瘤内PK特征（不作强制要求）；探索瘤内注射CNSI-Fe的瘤体大小与CNSI-Fe注射剂量、给药浓度间的量效关系（不作强制要求）。

[Translation]

Primary objective: To evaluate the safety and tolerability of different doses of intratumoral injection of nanocarbon iron suspension injection (CNSI-Fe) in patients with advanced solid tumors, observe the dose-limiting toxicity (DLT) of CNSI-Fe, determine the maximum tolerated dose (MTD) or the highest injection dose in humans, and provide a basis for dose selection for subsequent clinical studies. Secondary objective: To evaluate the pharmacokinetic (PK) characteristics of different doses of intratumoral injection of CNSI-Fe in patients with advanced solid tumors; to preliminarily evaluate the efficacy of different doses of intratumoral injection of CNSI-Fe in patients with advanced solid tumors. Exploratory objective: To evaluate the intratumoral pharmacodynamic (PD) characteristics of different doses of intratumoral injection of CNSI-Fe in patients with advanced solid tumors (not mandatory); to evaluate the intratumoral PK characteristics of different doses of intratumoral injection of CNSI-Fe in patients with advanced solid tumors (not mandatory); to explore the dose-effect relationship between the tumor size of intratumoral injection of CNSI-Fe and the injection dose and administration concentration of CNSI-Fe (not mandatory).

Start Date17 Nov 2022

Sponsor / Collaborator

Sichuan Yingrui Pharmaceutical Technology Co., Ltd.

100 Clinical Results associated with Chongqing Lummy Pharmaceutical Co., Ltd.

0 Patents (Medical) associated with Chongqing Lummy Pharmaceutical Co., Ltd.

Literatures (Medical) associated with Chongqing Lummy Pharmaceutical Co., Ltd.

01 Nov 2018·Materials Science and Engineering: CQ2 · ENGINEERING & TECHNOLOGY

Carbon nanoparticles suspension injection for the delivery of doxorubicin: Comparable efficacy and reduced toxicity

Q2 · ENGINEERING & TECHNOLOGY

Article

Author: Xin, Qian ; Zeng, Guangfu ; Xie, Ping ; Zhang, Xuemei ; Tang, Xiao-Hai ; Yang, Sheng-Tao ; Huang, Yuanfang

Drug delivery systems for doxorubicin (DOX) have attracted tremendous interest nowadays for the improved efficacy and/or reduced toxicity. Due to the aromatic structures and hydrophobic domains, carbon nanoparticle suspension injection (CNSI), a clinical applied reagent for lymph node mapping, strongly adsorbs DOX and holds great potential in cancer therapy. Herein, we evaluated the therapeutic effects of CNSI-DOX to establish its delivery applications for cancer drugs. CNSI adsorbed DOX from solution quickly after the mixing, and the release of DOX from CNSI followed a pH-dependent way. CNSI-DOX and free DOX had nearly identical inhibitive effects on cancer cells, while the vehicle CNSI was nontoxic. CNSI-DOX largely prolonged the life span of ascites tumor bearing mice after the intraperitoneally injection and the ascites weights showed significant decreases. CNSI-DOX also inhibited the growth of subcutaneous xenografts following the same administration route. The therapeutic efficacy of CNSI-DOX was similar to that of free DOX in ascites tumor model, but slightly lower in subcutaneous xenografts model. The advantage of using CNSI was majorly reflected by the reduced toxicity of DOX according to the bodyweight changes, serum biochemical indicators and histopathological observations. The LD₅₀ (median lethal dose) value of CNSI-DOX was 43.8 mg/kg bodyweight, nearly three times of that of free DOX (15.2 mg/kg bodyweight). Our results suggested that CNSI might be used for DOX delivery through "off label" use to benefit the patients immediately.

01 Jun 2018·Acta Chromatographica

Determination of adriamycin content in pectin–adriamycin conjugate in a two-phase reaction system by high-performance liquid chromatography

Author: Tang, Xiaohai ; Ran, Maosheng ; Xie, Ping ; Yang, Jinliang ; Zeng, Guangfu

A newly proposed method for detecting content of adriamycin in pectin–adriamycin conjugate has been developed and evaluated. The content of adriamycin was detected by selective degradation of adramycin to adriamycinone. It was realized by a two-phase reaction system (water–chloroform reaction system), in which adriamycin was quantitatively converted to adriamycinone. Therefore, the latter can be used to calculate the precise content of adramycin in the polymer drug. To develop the method, the catalyst for degradation, the extraction solvent for adriamycinone, the temperature and time of degradation, and the ratio of pectin–adriamycin conjugate were investigated. The optimal reaction condition was as follows: 30 mg of pectin–adriamycin conjugate dissolved in 25 mL of water was added to a mixture of 25 mL of hydrochloric acid (1.5 mol/L) and 50 mL of chloroform; the mixture was heated to 40 °C to react for 1.5 h; after that, the mixture was extracted with chloroform for three times, and then the organic layer was combined and, subsequently, evaporated to remove solvent. Under this condition, adriamycinone generation rate reached 99.87%. The quantitative method was evaluated for linearity, the limit of detection (LOD) and limit of quantitation (LOQ), recovery, accuracy, robustness, and precision. The recoveries were between 99.47% and 101.07% with relative standard deviation <1.23%. The LOD and LOQ were 0.06 and 0.17 μg/mL, respectively. Compared to the traditional ultraviolet (UV) detection, this method is considered to be more precise for detecting content of adriamycin in its polymer conjugate.

01 Aug 2013·Journal of Biomaterials ApplicationsQ4 · ENGINEERING & TECHNOLOGY

Preparation and in vitro characterization of dexamethasone-loaded poly(d,l-lactic acid) microspheres embedded in poly(ethylene glycol)–poly(ɛ-caprolactone)–poly(ethylene glycol) hydrogel for orthopedic tissue engineering

Q4 · ENGINEERING & TECHNOLOGY

Article

Author: Tang, XiaoHai ; Luo, Feng ; Fan, Min ; Guo, QingFa ; Qian, ZhiYong ; Xie, Ping ; Luo, JingCong

The corium is decreased to about half of its thickness in skin defects and wrinkles due to gravity and environment. In this study, dexamethasone/poly(d,l-lactic acid) ( Mn = 160,000) microspheres were incorporated into poly(ethylene glycol)–poly(ɛ-caprolactone)–poly(ethylene glycol) ( Mn = 3300) hydrogel to prepare an injectable hydrogel composite. The composite was designed to increase the thickness of the corium. Dexamethasone/poly(d,l-lactic acid) microspheres were prepared by oil-in-water emulsion/solvent evaporation technique. The properties of microspheres were investigated by size distribution measurement, scanning electron microscope and x-ray diffraction. Drug loading, encapsulation efficiency, and drug delivery behavior of microspheres were also studied in detail. Cell adhesion of microspheres was investigated by NIH3T3 cell in vitro. The properties of hydrogel composite were investigated by scanning electron microscope, rheological measurements and methyl thiazolyl tetrazolium assay. Drug release from composite was determined by HPLC-UV analysis. These results suggested that poly(d,l-lactic acid) microspheres encapsulating dexamethasone embedded in poly(ethylene glycol)–poly(ɛ-caprolactone)–poly(ethylene glycol) hydrogel might have prospective application in orthopedic tissue engineering field.

100 Deals associated with Chongqing Lummy Pharmaceutical Co., Ltd.

100 Translational Medicine associated with Chongqing Lummy Pharmaceutical Co., Ltd.

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Pipeline Snapshot as of 22 Nov 2024

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

Mycobacterium Phlei F.U.36	Tuberculosis More	Approved
CNSI-Fe	Advanced Malignant Solid Neoplasm More	Phase 2 Clinical
CUD-005 ( IL-1R x MMPs )	Liver Cirrhosis More	Phase 1
CUD002	Recurrent ovarian cancer More	Phase 1
CUD004	Liver Cancer More	Discontinued

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