Delving into the Latest Updates on Hongguan Bio-pharma Co., Ltd. with Synapse

Overview

主要研究目的：研究空腹和餐后状态下单次口服受试制剂普罗布考片（规格：0.25g，浙江皓格药业有限公司生产）与参比制剂普罗布考片（Lorelco®，规格：250mg，大塚製薬株式会社生产）在健康成年研究参与者体内的吸收速度和吸收程度的差异。次要研究目的：空腹和餐后状态下，研究单次口服受试制剂普罗布考片和参比制剂普罗布考片（Lorelco®）在健康成年研究参与者中的安全性。

[Translation]

Primary study objective: To investigate the differences in absorption rate and extent of a single oral dose of the test formulation probucol tablets (0.25g, manufactured by Zhejiang Haoge Pharmaceutical Co., Ltd.) and the reference formulation probucol tablets (Lorelco®, 250mg, manufactured by Otsuka Pharmaceutical Co., Ltd.) in healthy adult study participants under fasting and postprandial conditions. Secondary study objective: To investigate the safety of a single oral dose of the test formulation probucol tablets and the reference formulation probucol tablets (Lorelco®) in healthy adult study participants under fasting and postprandial conditions.

Start Date16 Dec 2025

Sponsor / Collaborator

Hongguan Bio-pharma Co., Ltd.

CTR20251114

/ CompletedNot Applicable

氢溴酸替格列汀片在健康受试者中空腹和餐后状态下的单剂量、随机、开放、两周期、两序列、交叉设计的生物等效性试验

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

主要研究目的：试验空腹和餐后状态下单次口服受试制剂氢溴酸替格列汀片（规格：20mg，浙江皓格药业有限公司生产）与参比制剂氢溴酸替格列汀片（Tenelia（泰里安），规格：20mg，Mitsubishi Tanabe Pharma Factory Ltd.,Yoshitomi Plant生产）在健康成年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。次要研究目的：空腹和餐后状态下，试验单次口服氢溴酸替格列汀片受试制剂和参比制剂（商品名Tenelia（泰里安））在健康成年受试者中的安全性。

[Translation]

Main study objectives: To test the pharmacokinetics of the test preparation of the test preparation of the hydrobromide tablets of tenegliptin (specification: 20mg, produced by Zhejiang Haoge Pharmaceutical Co., Ltd.) and the reference preparation of the hydrobromide tablets of tenegliptin (Tenelia, specification: 20mg, produced by Mitsubishi Tanabe Pharma Factory Ltd., Yoshitomi Plant) in healthy adult subjects in the fasting and fed state, and to evaluate the bioequivalence of the two preparations in the fasting and fed state. Secondary study objectives: To test the safety of the test preparation of the hydrobromide tablets of tenegliptin and the reference preparation (trade name Tenelia) in healthy adult subjects in the fasting and fed state.

Start Date18 Apr 2025

Sponsor / Collaborator

Hongguan Bio-pharma Co., Ltd.

NCT04275492

/ TerminatedNot ApplicableIIT

Study on Bioequivalence of Pramipexole Dihydrochloride Sustained Release Tablets

The main purpose of In two kinds of fasting and postprandial Chinese healthy subjects with Boehringer represent Ingelheim company production of hydrochloric acid Pramipexole zyban (specification: 0.26 mg/piece, in Pramipexole, commodity name: Siforl ®) as the reference preparation, study a single oral dose of macro crown biological pharmaceutical co., LTD. Production of Pramipexole Dihydrochloride Sustained Release Tablets (specification:The pharmacokinetic parameters of the drug were calculated after the time course of the drug in vivo (0.375mg/ tablet, as measured by pramipexole hydrochloride), and the human relative bioavailability of the two preparations were compared to evaluate their bioequivalence.
A secondary purpose To evaluate the safety of fasting and postprandial oral test preparations and reference preparations.

Start Date24 Jul 2020

Sponsor / Collaborator