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

Overview

主要研究目的：研究空腹状态下单次口服受试制剂盐酸右哌甲酯片（规格：2.5 mg，河南中帅药业有限公司生产）与参比制剂盐酸右哌甲酯片（Focalin®，规格：2.5 mg，Mikart, LLC生产）在健康成年受试者体内的药代动力学参数，评价空腹状态口服两种制剂的生物等效性。次要研究目的：评估受试制剂盐酸右哌甲酯片（规格：2.5 mg）和参比制剂盐酸右哌甲酯片（Focalin®，规格：2.5 mg）在健康成年受试者中的安全性。

[Translation]

The main purpose of the study is to study the pharmacokinetic parameters of the test preparation dexmethylphenidate hydrochloride tablets (specification: 2.5 mg, produced by Henan Zhongshuai Pharmaceutical Co., Ltd.) and the reference preparation dexmethylphenidate hydrochloride tablets (Focalin®, specification: 2.5 mg, produced by Mikart, LLC) in healthy adult subjects after a single oral administration in the fasting state, and to evaluate the bioequivalence of the two preparations in the fasting state. Secondary purpose of the study: to evaluate the safety of the test preparation dexmethylphenidate hydrochloride tablets (specification: 2.5 mg) and the reference preparation dexmethylphenidate hydrochloride tablets (Focalin®, specification: 2.5 mg) in healthy adult subjects.

Start Date25 Feb 2025

Sponsor / Collaborator

Henan Zhongshuai Pharmaceutical Co., Ltd.

CTR20233119

/ CompletedNot Applicable

乙酰唑胺片在中国健康受试者中的单次给药、随机、开放、两周期、双交叉、空腹及餐后状态下的生物等效性研究

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

主要研究目的：以Taro Pharmaceuticals U.S.A., Inc.持证的乙酰唑胺片（规格：250 mg）为参比制剂，以河南中帅药业有限公司研发的乙酰唑胺片（规格：0.25 g）为受试制剂，通过单中心、单次给药、随机、开放、两周期、双交叉设计的临床研究来评价两种制剂在空腹和餐后状态下的人体生物等效性。次要研究目的：观察受试制剂和参比制剂在中国健康受试者中的安全性。

[Translation]

The main purpose of the study is to use the acetazolamide tablets (specification: 250 mg) licensed by Taro Pharmaceuticals U.S.A., Inc. as the reference preparation and the acetazolamide tablets (specification: 0.25 g) developed by Henan Zhongshuai Pharmaceutical Co., Ltd. as the test preparation to evaluate the bioequivalence of the two preparations in the fasting and fed state through a single-center, single-dose, randomized, open, two-period, double-crossover clinical study. Secondary purpose of the study: to observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.

Start Date16 Oct 2023

Sponsor / Collaborator

Henan Zhongshuai Pharmaceutical Co., Ltd.

CTR20231401

/ CompletedPhase 3

评价乙酰唑胺缓释胶囊预防急性高山病有效性和安全性的多中心、随机、双盲、安慰剂、平行对照Ⅲ期临床试验

[Translation] A multicenter, randomized, double-blind, placebo-controlled, parallel-controlled phase III clinical trial to evaluate the efficacy and safety of acetazolamide extended-release capsules in preventing acute mountain sickness

主要目的：与安慰剂对照，评价乙酰唑胺缓释胶囊预防急性高山病的有效性。次要目的：评价乙酰唑胺缓释胶囊预防急性高山病的安全性。

[Translation]

Primary objective: To evaluate the effectiveness of acetazolamide extended-release capsules in preventing acute mountain sickness compared with placebo. Secondary objective: To evaluate the safety of acetazolamide extended-release capsules in preventing acute mountain sickness.

Start Date06 Jun 2023

Sponsor / Collaborator