Delving into the Latest Updates on Huayi Pharmaceutical Technology (Anhui) Co., Ltd. with Synapse

Overview

研究空腹状态下单次口服受试制剂（乙酰半胱氨酸片，规格0.6g，华益药业科技(安徽)有限公司生产）与参比制剂（乙酰半胱氨酸片，规格600mg，商品名：Fluimucil，Zambon S.p.A.生产）在健康受试者体内的药代动力学特征，比较受试制剂与参比制剂的生物等效性，并研究药物在健康受试者体内的安全性。

[Translation]

The pharmacokinetic characteristics of a single oral dose of the test preparation (acetylcysteine tablets, specification 0.6g, produced by Huayi Pharmaceutical Technology (Anhui) Co., Ltd.) and the reference preparation (acetylcysteine tablets, specification 600mg, trade name: Fluimucil, produced by Zambon S.p.A.) in healthy subjects under fasting state were studied, the bioequivalence of the test preparation and the reference preparation was compared, and the safety of the drug in healthy subjects was studied.

Start Date09 Feb 2025

Sponsor / Collaborator

Huayi Pharmaceutical Technology (Anhui) Co., Ltd.

CTR20244761

/ CompletedNot Applicable

培哚普利叔丁胺片在健康参与者中空腹条件下开放、随机、单次给药、两制剂、两序列、两周期交叉设计生物等效性试验

[Translation] An open, randomized, single-dose, two-formulation, two-sequence, two-period crossover bioequivalence study of perindopril tert-butylamine tablets in healthy participants under fasting conditions

研究空腹状态下单次口服受试制剂（培哚普利叔丁胺片，规格8mg，华益药业科技（安徽）有限公司持证）与参比制剂（培哚普利叔丁胺片，规格8mg，商品名雅施达®，施维雅（天津）制药有限公司持证）在健康参与者体内的药代动力学特征，比较受试制剂与参比制剂的生物等效性，并研究药物在健康参与者体内的安全性。

[Translation]

To study the pharmacokinetic characteristics of a single oral dose of the test preparation (Perindopril tert-butylamine tablets, specification 8 mg, licensed by Huayi Pharmaceutical Technology (Anhui) Co., Ltd.) and the reference preparation (Perindopril tert-butylamine tablets, specification 8 mg, trade name Yashida®, licensed by Servier (Tianjin) Pharmaceutical Co., Ltd.) in healthy participants under fasting state, to compare the bioequivalence of the test preparation and the reference preparation, and to study the safety of the drug in healthy participants.

Start Date23 Dec 2024

Sponsor / Collaborator

Huayi Pharmaceutical Technology (Anhui) Co., Ltd.

CTR20244318

/ RecruitingPhase 3

一项在他汀类药物控制不佳的高脂血症患者中评估贝派度酸片疗效、耐受性和安全性的III期临床研究

[Translation] A phase III clinical study to evaluate the efficacy, tolerability and safety of bepedrucic acid tablets in patients with hyperlipidemia who are not well controlled by statins

主要研究目的：评估贝派度酸片在他汀类药物控制不佳的高脂血症患者中的疗效。次要研究目的：评估贝派度酸片在他汀类药物控制不佳的高脂血症患者中的疗效、耐受性和安全性。

[Translation]

Primary study objective: To evaluate the efficacy of bepedrucic acid tablets in patients with hyperlipidemia who are not well controlled by statins. Secondary study objective: To evaluate the efficacy, tolerability and safety of bepedrucic acid tablets in patients with hyperlipidemia who are not well controlled by statins.

Start Date20 Dec 2024

Sponsor / Collaborator