Delving into the Latest Updates on Jilin Boda Weiye Pharmaceutical Co. Ltd. with Synapse

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Digestive System Disorders

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[Translation] A single-center, randomized, open-label, single-dose, two-period, two-sequence, crossover bioequivalence study to evaluate the test formulation of polyprezinc granules (strength: 0.5 g: 75 mg) and the reference formulation (Promac®) (strength: 0.5 g: 75 mg) 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聚普瑞锌颗粒（规格：0.5 g:75 mg，持证商：吉林省博大伟业制药有限公司）与参比制剂聚普瑞锌颗粒（Promac®，规格：0.5 g:75 mg，持证商：ゼリア新薬工業株式会社）在健康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。

[Translation]

Main research purpose: To study the single oral administration of the test preparation Polyprex zinc granules (specification: 0.5 g: 75 mg, license holder: Jilin Boda Weiye Pharmaceutical Co., Ltd.) and the reference preparation Juprex Pharmacokinetics of zinc granules (Promac®, specifications: 0.5 g: 75 mg, licensee: Seiko Shinsui Industrial Co., Ltd.) in healthy subjects, and evaluation of the bioequivalence of two oral formulations in fasting and postprandial states sex.

Start Date18 May 2023

Sponsor / Collaborator

Jilin Boda Weiye Pharmaceutical Co. Ltd.

CTR20202184 / CompletedNot Applicable

聚普瑞锌颗粒75mg随机、开放、两周期、两交叉健康受试者空腹状态下生物等效性试验

[Translation] A randomized, open-label, two-period, two-crossover bioequivalence study of 75 mg polyprene zinc granules in healthy subjects under fasting conditions

主要研究目的研究空腹状态下单次口服受试制剂T（聚普瑞锌颗粒75mg/袋，吉林省博大伟业制药有限公司生产）与参比制剂R（聚普瑞锌颗粒Promac ®，75 mg/袋，ZERIA新药工业株式会社生产）在健康受试者体内的药代动力学特征，评价空腹状态下口服两种制剂的生物等效性。次要研究目的评价受试制剂T与参比制剂R在健康受试者中的安全性。

[Translation]

Main study objectives To study the pharmacokinetic characteristics of the test preparation T (Poprezinc granules 75 mg/bag, produced by Jilin Boda Weiye Pharmaceutical Co., Ltd.) and the reference preparation R (Poprezinc granules Promac ®, 75 mg/bag, produced by ZERIA Pharmaceutical Industry Co., Ltd.) in healthy subjects after a single oral administration under fasting conditions, and to evaluate the bioequivalence of the two preparations when taken orally under fasting conditions. Secondary study objectives To evaluate the safety of the test preparation T and the reference preparation R in healthy subjects.

Start Date04 Dec 2020

Sponsor / Collaborator

Jilin Boda Weiye Pharmaceutical Co. Ltd.

CTR20202186 / CompletedNot Applicable

聚普瑞锌颗粒75mg随机、开放、两周期、两交叉健康受试者餐后状态下生物等效性试验

[Translation] A randomized, open-label, two-period, two-crossover bioequivalence study of polyprezinc granules 75 mg in healthy subjects in the fed state

主要研究目的研究餐后状态下单次口服受试制剂T（聚普瑞锌颗粒75mg/袋，吉林省博大伟业制药有限公司生产）与参比制剂R（聚普瑞锌颗粒Promac ®，75 mg/袋，ZERIA新药工业株式会社生产）在健康受试者体内的药代动力学特征，评价餐后状态下口服两种制剂的生物等效性。次要研究目的评价受试制剂T与参比制剂R在健康受试者中的安全性。

[Translation]

Main study objectives To study the pharmacokinetic characteristics of the test formulation T (Poprezinc granules 75 mg/bag, produced by Jilin Boda Weiye Pharmaceutical Co., Ltd.) and the reference formulation R (Poprezinc granules Promac ®, 75 mg/bag, produced by ZERIA Pharmaceutical Industry Co., Ltd.) in healthy subjects after a single oral administration in the fed state, and to evaluate the bioequivalence of the two formulations after oral administration in the fed state. Secondary study objectives To evaluate the safety of the test formulation T and the reference formulation R in healthy subjects.

Start Date03 Dec 2020

Sponsor / Collaborator

Jilin Boda Weiye Pharmaceutical Co. Ltd.

100 Clinical Results associated with Jilin Boda Weiye Pharmaceutical Co. Ltd.

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0 Patents (Medical) associated with Jilin Boda Weiye Pharmaceutical Co. Ltd.

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100 Deals associated with Jilin Boda Weiye Pharmaceutical Co. Ltd.

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100 Translational Medicine associated with Jilin Boda Weiye Pharmaceutical Co. Ltd.

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Pipeline

Pipeline Snapshot as of 28 Dec 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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