[Translation] A single-center, randomized, open-label, two-sequence, two-period, crossover bioequivalence study of trazodone hydrochloride tablets in the fasting and fed state in healthy Chinese people

主要目的：以福建省闽东力捷迅药业股份有限公司生产的盐酸曲唑酮片为受试制剂，按有关生物等效性试验的规定，以オルガノン株式会社持证的盐酸曲唑酮片(商品名:RESLIN®)为参比制剂，评估两种制剂空腹和餐后给药的生物等效性。次要目的：评价福建省闽东力捷迅药业股份有限公司生产的盐酸曲唑酮片空腹和餐后单次口服给药的药代动力学(PK)特点。评价福建省闽东力捷迅药业股份有限公司生产的盐酸曲唑酮片的安全性。

[Translation]

Main purpose: To evaluate the bioequivalence of the two preparations in fasting and postprandial administration, using trazodone hydrochloride tablets produced by Fujian Mindong Lijiexun Pharmaceutical Co., Ltd. as the test preparation and trazodone hydrochloride tablets (trade name: RESLIN®) certified by Olganon Co., Ltd. as the reference preparation according to the relevant provisions of bioequivalence tests. Secondary purpose: To evaluate the pharmacokinetic (PK) characteristics of fasting and postprandial single oral administration of trazodone hydrochloride tablets produced by Fujian Mindong Lijiexun Pharmaceutical Co., Ltd. To evaluate the safety of trazodone hydrochloride tablets produced by Fujian Mindong Lijiexun Pharmaceutical Co., Ltd.

Start Date08 Apr 2024

Sponsor / Collaborator

Fujian Mindong Rejuenation Pharmaceutical Co., Ltd.

CTR20233547 / CompletedNot Applicable

磷酸奥司他韦胶囊在中国健康人群中空腹和餐后状态下单中心、随机、开放、两序列、两周期、交叉生物等效性试验

[Translation] A single-center, randomized, open-label, two-sequence, two-period, crossover bioequivalence study of oseltamivir phosphate capsules in the fasting and fed state in healthy Chinese people

主要目的：以福建省闽东力捷迅药业股份有限公司生产的磷酸奥司他韦胶囊作为受试制剂，按有关生物等效性试验的规定，以 Roche Pharma (Schweiz) AG 持证的磷酸奥司他韦胶囊（商品名：达菲®）为参比制剂，评估两种制剂空腹和餐后给药的生物等效性。次要目的：评价福建省闽东力捷迅药业股份有限公司生产的磷酸奥司他韦胶囊空腹和餐后单次口服给药的药代动力学（PK）特点；评价福建省闽东力捷迅药业股份有限公司生产的磷酸奥司他韦胶囊的安全性。

[Translation]

Primary objective: Oseltamivir phosphate capsules produced by Fujian Mindong Lijiexun Pharmaceutical Co., Ltd. were used as the test preparation. According to the relevant provisions of bioequivalence tests, Roche Pharma (Schweiz) AG's certified oseltamivir phosphate capsules (trade name: Tamiflu®) were used as the reference preparation to evaluate the bioequivalence of the two preparations when administered on an empty stomach or after a meal. Secondary objective: To evaluate the pharmacokinetic (PK) characteristics of single oral administration of oseltamivir phosphate capsules produced by Fujian Mindong Lijiexun Pharmaceutical Co., Ltd. on an empty stomach or after a meal; to evaluate the safety of oseltamivir phosphate capsules produced by Fujian Mindong Lijiexun Pharmaceutical Co., Ltd.

Start Date29 Nov 2023

Sponsor / Collaborator

Fujian Mindong Rejuenation Pharmaceutical Co., Ltd.

CTR20233093 / CompletedNot Applicable

磷酸奥司他韦干混悬剂在中国健康人群中空腹和餐后状态下单中心、随机、开放、两序列、两周期、交叉生物等效性试验

[Translation] A single-center, randomized, open-label, two-sequence, two-period, crossover bioequivalence study of oseltamivir phosphate dry suspension in Chinese healthy subjects under fasting and fed conditions

主要研究目的以福建省闽东力捷迅药业股份有限公司生产的磷酸奥司他韦干混悬剂为受试制剂，按有关生物等效性试验的规定，以Hoffmann La Roche Inc持证的磷酸奥司他韦干混悬剂（商品名： Tarniflu® ) 为参比制剂，评估两种制剂空腹和餐后条件下给药的生物等效性。次要研究目的评估受试制剂磷酸奥司他韦干混悬剂和参比制剂 Tarniflu® 在中国健康成年受试者中的安全性。

[Translation]

Main study objectives The oseltamivir phosphate suspension produced by Fujian Mindong Lijiexun Pharmaceutical Co., Ltd. was used as the test preparation. According to the relevant provisions of the bioequivalence test, the oseltamivir phosphate suspension (trade name: Tarniflu®) certified by Hoffmann La Roche Inc was used as the reference preparation to evaluate the bioequivalence of the two preparations under fasting and postprandial conditions. Secondary study objectives Evaluate the safety of the test preparation oseltamivir phosphate suspension and the reference preparation Tarniflu® in healthy adult subjects in China.

Start Date22 Oct 2023

Sponsor / Collaborator

Fujian Mindong Rejuenation Pharmaceutical Co., Ltd.

100 Clinical Results associated with Fujian Mindong Rejuenation Pharmaceutical Co., Ltd.

0 Patents (Medical) associated with Fujian Mindong Rejuenation Pharmaceutical Co., Ltd.

Literatures (Medical) associated with Fujian Mindong Rejuenation Pharmaceutical Co., Ltd.

Zhongguo Shenghua Yaowu Zazhi

Research advances in citicoline-a neuroprotective agent

Author: Zhou, Changkui ; Wu, Xiaohua

A review on a neuroprotective agent citicoline with subdivision headings: (1) chem. structure and metabolism of citicoline; (2) animal model and clin. application studies; (3) mechanism of action; and (4) prospect.

Zhongguo Yaowu Huaxue Zazhi

Synthesis of antiallergic drug,rupatifen fumarate and preparation and characterization of its crystal A

Author: Li Lin ; Zhang Ya-shan ; Yang Min ; Lin Wei ; Wang Hai-yan ; Lin Peng-fei

In this study,a new national anti-allergic drug,rupatifen fumarate,was developed and a new crystalline form of rupatifen fumarate(crystal A) was preparedThe target compound was synthesized by acid addition salt method,and the crystal type A was characterized by powder X-ray diffraction,differential scanning calorimetry(DSC),scanning electron microscope and other phys. methods.The characterization results showed that the crystal type A was a rod-shaped crystal,the characteristic peak of crystal A was(2θ±0.2)° at 13.6°(23%),21.2°(30%),29.1°(40%).Its m.p. was(154±2) °C and decomposition occurs at about(180±2)°C.Through the study,the compound and crystal A of rupatifen fumarate were of great reference significance for the development of proprietary drugs of rupatifen fumarate.♂

Zhongguo Yaoke Daxue Xuebao

Preparation process and structure confirmation of impurity C of rupatifen fumarate

Author: Li Lin ; Wang Xiaoming ; Lin Pengfei ; Meng Shufang ; Chen Ling ; Chen Lin ; Wang Haiyan

The high-purity impurity C was isolated and purified from a new anti-allergic drug, rupatifen, by nucleophilic substitution reaction with bromobutaric acid, and its structure was confirmed by IR, UV, MS,1 H NMR,13 C NMR, DEPT135°,HSQC, HMBC, and1 H-1 HCOSY.The preparation process of impurity C in this study was simple and easy to obtain under mild conditions, with the purity of 99.0% and the yield of 25%-30%;and the sample met the target compound by structural confirmation.The preparation process and structure confirmation provided sufficient impurity C reference substance for impurity research of raw materials and preparations of rupatifen fumarate, which laid a solid foundation for quality research of new drugs.

100 Deals associated with Fujian Mindong Rejuenation Pharmaceutical Co., Ltd.

100 Translational Medicine associated with Fujian Mindong Rejuenation Pharmaceutical Co., Ltd.

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Drug(Targets)	Indications	Global Highest Phase

DX-01	Trichomonas Vaginitis More	Phase 3
Rupatifen fumarate ( Histamine receptor x PAF receptor )	Rhinitis, Allergic, Seasonal More	Phase 2

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