[Translation] A single-dose, randomized, open-label, three-period, partially repeated crossover, bioequivalence study of azithromycin granules (0.1 g) in Chinese healthy subjects under fasting and fed conditions

主要研究目的：以辉瑞制药有限公司生产的阿奇霉素干混悬剂（商品名：希舒美®；0.1 g）为参比制剂，以海口奇力制药股份有限公司生产的阿奇霉素颗粒（0.1 g）为受试制剂，通过单中心、随机、开放、单次给药、三周期、部分重复交叉临床研究来评价两种制剂在空腹和餐后状态下的人体生物等效性。次要研究目的：观察受试制剂和参比制剂在中国健康受试者中的安全性。

[Translation]

The main purpose of the study is to use azithromycin dry suspension (trade name: Xishumei®; 0.1 g) produced by Pfizer Pharmaceuticals Co., Ltd. as the reference preparation and azithromycin granules (0.1 g) produced by Haikou Qili Pharmaceutical Co., Ltd. as the test preparation to evaluate the bioequivalence of the two preparations in the fasting and fed state through a single-center, randomized, open, single-dose, three-period, partially repeated crossover clinical study. Secondary purpose of the study: To observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.

Start Date06 Apr 2024

Sponsor / Collaborator

Haikou Qili Pharmaceutical Co., Ltd.

CTR20222035 / CompletedNot Applicable

阿昔洛韦片人体生物等效性研究

[Translation] Study on the bioequivalence of acyclovir tablets in human body

本试验旨在研究单次空腹和餐后口服海口奇力制药股份有限公司研制、生产的阿昔洛韦片（0.2 g）的药代动力学特征；以葛兰素史克株式会社生产的阿昔洛韦片（Zovirax®，200 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 acyclovir tablets (0.2 g) developed and produced by Haikou Qili Pharmaceutical Co., Ltd. after single oral administration on an empty stomach or after a meal. Acyclovir tablets (Zovirax®, 200 mg) produced by GlaxoSmithKline were 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 Date11 Sep 2022

Sponsor / Collaborator

Haikou Qili Pharmaceutical Co., Ltd.

CTR20202533 / RecruitingPhase 1/2

多中心、开放、剂量递增、单次/多次给药评价注射用重组人钙调蛋白磷酸酶B治疗中国晚期肝癌、胃癌患者的安全性、耐受性、药代动力学及初步药效学的临床试验

[Translation] A multicenter, open-label, dose-escalation, single/multiple-dose clinical trial to evaluate the safety, tolerability, pharmacokinetics and preliminary pharmacodynamics of recombinant human calcineurin B for injection in the treatment of Chinese patients with advanced liver cancer and gastric cancer

主要目的： ①本研究选择中国晚期肝癌、胃癌患者为试验对象，考察中国晚期肝癌、胃癌患者单药给予注射用重组人钙调蛋白磷酸酶B的安全性、耐受性，确定最大耐受剂量（MTD）； ②评价注射用重组人钙调蛋白磷酸酶B单/多次给药在中国晚期肝癌、胃癌患者体内的药代动力学（pharmacokinetics，PK）特征。次要目的： ①评价注射用重组人钙调蛋白磷酸酶B在中国晚期肝癌、胃癌患者的单/多次给药后免疫原性特征； ②初步评价注射用重组人钙调蛋白磷酸酶B在中国晚期肝癌、胃癌患者的药效动力学（pharmacodynamics，PD）指标。探索性目的： ①初步探索注射用重组人钙调蛋白磷酸酶B治疗晚期肝癌、胃癌患者的临床有效性及有效剂量范围； ②初步探索注射用重组人钙调蛋白磷酸酶B疗效的生物标志物。

[Translation]

Main objectives: ①This study selected Chinese patients with advanced liver cancer and gastric cancer as test subjects to investigate the safety and tolerability of single-drug recombinant human calcineurin B for injection in Chinese patients with advanced liver cancer and gastric cancer, and determine the maximum tolerated dose (MTD); ②Evaluate the pharmacokinetic (PK) characteristics of single/multiple administration of recombinant human calcineurin B for injection in Chinese patients with advanced liver cancer and gastric cancer. Secondary objectives: ①Evaluate the immunogenicity characteristics of recombinant human calcineurin B for injection after single/multiple administration in Chinese patients with advanced liver cancer and gastric cancer; ②Preliminary evaluation of the pharmacodynamics (PD) indicators of recombinant human calcineurin B for injection in Chinese patients with advanced liver cancer and gastric cancer. Exploratory objectives: ①Preliminary exploration of the clinical efficacy and effective dose range of recombinant human calcineurin B for injection in the treatment of patients with advanced liver cancer and gastric cancer; ②Preliminary exploration of biomarkers of the efficacy of recombinant human calcineurin B for injection.

Start Date02 Mar 2021

Sponsor / Collaborator

Beijing Normal University

[+1]

100 Clinical Results associated with Haikou Qili Pharmaceutical Co., Ltd.

0 Patents (Medical) associated with Haikou Qili Pharmaceutical Co., Ltd.

Literatures (Medical) associated with Haikou Qili Pharmaceutical Co., Ltd.

01 Jun 2016·Science China Life SciencesQ1 · BIOLOGY

Quality-control method for the determination of biological activity of engineered calcineurin subunit B

Q1 · BIOLOGY

Article

Author: Han, Yudong ; Rao, Chunming ; Yang, Huan ; Shi, Xinchang ; Li, Xiang ; Huang, Zongwen ; Xu, Li ; Wei, Qun

The aim of this study was to establish a quality-control method for calcineurin subunit B (CNB) biological activity determinations. CNB enhances the p-nitrophenylphosphate (pNPP) dephosphorylating activity of calcineurin subunit A Δ316 mutant (CNAΔ316). A series of CNB concentrations were fitted to a four-parameter equation to calculate the corresponding pNPP maximum dephosphorylation rates. Values were calculated based on biological activity references using a parallel line method. The method was then validated for accuracy, precision, linearity, linear range, sensitivity, specificity, and robustness. The recovery results were greater than 98%. Intra-plate precision was 6.7%, with inter-plate precision of 10.8%. The coefficient of determination was greater than 0.98. The linear range was 0.05-50 μg mL(-1), with sensitivity of 50 μg mL(-1). Tested cytokines did not induce CNAΔ316 dephosphorylation of pNPP. The chosen CNAΔ316 concentration range did not affect activity determinations.

Zhongguo Redai Yixue

Determination of content of netilmicin sulfate injection by using high performance liquid chromatography

Author: Weng, Demin ; Chen, Weibo ; Yang, Li

Content of netilmicin was determined by using high performance liquid chromatog.The anal. column was Diamonsil-C₁₈, the mobile phase was 1.5% potassium dihydrogen phosphate (pH 2.5 adjusted by phosphoric acid)-acetonitrile (500:100) with 1.0 mL/min of flow rate, and the detective wavelength was 205 nm.External standard method was used.The standard curve of netilmicin sulfate was linear in the concentration range of 0.1-1.6 mg/mL (r = 0.9998), and the average recovery was 99.5%, RSD = 0.4% (n = 9).High performance liquid chromatog. is a simple, rapid and accurate method for determination of the content of netilmicin sulfate injection.

Hainan Yixueyuan Xuebao

Bacterial endotoxin test using cefoperazone sodium and sulbactam sodium for injection

Author: Zeng, Zhi-min ; Shi, Hai-li ; Sun, Fa-yan ; Hao, Jing-gang ; Han, Ke-sheng ; Chen, Jun-xian

To establish method of bacterial endotoxin test with cefoperazone sodium and sulbactam sodium for injection.The test result of the above mentioned method were evaluated with the bacterial endotoxin test method that was described in the Appendix XI E of Chinese Pharmacopoeia, 2005 edition.Compare the result with that of using pyrogen test method.Bacterial endotoxin test method using cefoperazone sodium and sulbactam sodium for injection was interference free to the result, and the limit value can be defined as high as 0.13 EU/mg.The bacterial endotoxin test method using cefoperazone sodium and sulbactam sodium for injection can replace the rabbit pyrogen test to control the heat source.

100 Deals associated with Haikou Qili Pharmaceutical Co., Ltd.

100 Translational Medicine associated with Haikou Qili Pharmaceutical Co., Ltd.

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Pipeline

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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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Harringtonine	Myelodysplastic Syndromes More	Approved
Ceftriaxone Sodium/Tazobactam Sodium ( PBPs x β-lactamase )	Bacterial Infections More	Approved
Recombinant human Calcineurin B subunit(Haikou Qili Pharmaceutical) ( CaM )	Liver Cancer More	Phase 2 Clinical

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