Delving into the Latest Updates on Hemony Pharmaceutical Co., Ltd. with Synapse

Overview

本研究以美时化学制药股份有限公司南投厂生产的盐酸曲唑酮片（规格：50 mg）为受试制剂，按生物等效性研究的有关规定，以原研厂家オルガノン株式会社生产的盐酸曲唑酮片（规格：50 mg，商品名：RESLIN®）为参比制剂，评估受试制剂和参比制剂在餐后条件下给药后的生物等效性。

[Translation]

In this study, trazodone hydrochloride tablets (specification: 50 mg) produced by the Nantou Plant of Meishi Chemical Pharmaceutical Co., Ltd. were used as the test preparation. According to the relevant regulations of bioequivalence studies, trazodone hydrochloride tablets (specification: 50 mg, trade name: RESLIN®) produced by the original manufacturer Olganon Co., Ltd. were used as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation after administration under fed conditions.

Start Date-

Sponsor / Collaborator

Chongqing Hemony Pharmaceutical Co., Ltd.

CTR20210374

/ CompletedNot Applicable

评估骨化三醇胶丸受试制剂与参比制剂在健康成年受试者空腹和餐后状态下的单中心、开放、随机、单剂量、两周期、两序列、交叉生物等效性研究

[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study to evaluate the calcitriol softgels test formulation and reference formulation in healthy adult subjects under fasting and fed conditions

研究空腹和餐后状态下单次口服受试制剂骨化三醇胶丸（海尼威，规格：0.25 μg）与参比制剂骨化三醇胶丸（罗盖全；规格：0.25 μg）在健康成年受试者体内的药代动力学特征，评价空腹和餐后状态口服两种制剂的生物等效性。次要试验目的：研究受试制剂骨化三醇胶丸（海尼威，规格：0.25 μg）和参比制剂骨化三醇胶丸（罗盖全，规格：0.25 μg）在健康成年受试者中的安全性。

[Translation]

To study the pharmacokinetic characteristics of a single oral administration of the test preparation calcitriol capsule (Heniwei, specification: 0.25 μg) and the reference preparation calcitriol capsule (Luogequan; specification: 0.25 μg) 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 study the safety of the test preparation calcitriol capsule (Heniwei, specification: 0.25 μg) and the reference preparation calcitriol capsule (Luogequan, specification: 0.25 μg) in healthy adult subjects.

Start Date11 Jan 2021

Sponsor / Collaborator

Hemony Pharmaceutical Co., Ltd.

CTR20182015

/ CompletedPhase 2

布地奈德气雾剂治疗成人支气管哮喘有效性和安全性的多中心、随机、盲法、阳性药物平行对照、非劣效临床试验

[Translation] A multicenter, randomized, blinded, positive drug parallel controlled, non-inferiority clinical trial on the efficacy and safety of budesonide aerosol in the treatment of adult bronchial asthma

评价布地奈德气雾剂用于治疗成人支气管哮喘的有效性和安全性

[Translation]

To evaluate the efficacy and safety of budesonide aerosol in the treatment of bronchial asthma in adults

Start Date22 Apr 2019

Sponsor / Collaborator