Delving into the Latest Updates on Fujian Dapu Bio-pharmaceutical Co., Ltd with Synapse

Overview

本试验旨在研究单次空腹和餐后口服福建大谱生物医药有限公司持证、湖南九典制药股份有限公司生产的坎地氢噻片（16 mg/12.5 mg）的药代动力学特征；以CHEPLAPHARM Arzneimittel GmbH持证、Delpharm Novara S.r.l.生产的坎地氢噻片（Blopress®，16 mg/12.5 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]

This study aims to study the pharmacokinetic characteristics of candecyrrhizic tablets (16 mg/12.5 mg) after single oral administration on an empty stomach or after a meal. Candecyrrhizic tablets (Blopress®, 16 mg/12.5 mg), licensed by Fujian Dapu Biopharmaceutical Co., Ltd. and produced by Hunan Jiudian Pharmaceutical Co., Ltd., 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 Date-

Sponsor / Collaborator

Fujian Dapu Bio-pharmaceutical Co., Ltd

CTR20243252

/ CompletedNot Applicable

坎地氢噻片在健康受试者中空腹及餐后状态下随机、开放、单剂量、两制剂、两周期、两序列交叉设计生物等效性试验方案

[Translation] A randomized, open-label, single-dose, two-formulation, two-period, two-sequence crossover bioequivalence study of candeserthi tablets in healthy subjects under fasting and fed conditions

本试验旨在研究单次空腹和餐后口服福建大谱生物医药有限公司持证、湖南九典制药股份有限公司生产的坎地氢噻片（16 mg/12.5 mg）的药代动力学特征；以CHEPLAPHARM Arzneimittel GmbH持证、Delpharm Novara S.r.l.生产的坎地氢噻片（Blopress®，16 mg/12.5 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]

This study aims to study the pharmacokinetic characteristics of candecyrrhizic tablets (16 mg/12.5 mg) after single oral administration on an empty stomach or after a meal. Candecyrrhizic tablets (Blopress®, 16 mg/12.5 mg), licensed by Fujian Dapu Biopharmaceutical Co., Ltd. and produced by Hunan Jiudian Pharmaceutical Co., Ltd., 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 Date20 Sep 2024

Sponsor / Collaborator

Fujian Dapu Bio-pharmaceutical Co., Ltd

100 Clinical Results associated with Fujian Dapu Bio-pharmaceutical Co., Ltd

Login to view more data

0 Patents (Medical) associated with Fujian Dapu Bio-pharmaceutical Co., Ltd

Login to view more data

100 Deals associated with Fujian Dapu Bio-pharmaceutical Co., Ltd

Login to view more data

100 Translational Medicine associated with Fujian Dapu Bio-pharmaceutical Co., Ltd

Login to view more data