Delving into the Latest Updates on Hainan Huiyuantang Pharmaceutical Co Ltd with Synapse

Overview

Basic Info

Introduction

Hui Yuan Tang Pharmaceutical Co., Ltd. is nestled on Hainan Island and specializes in the modern production of pure and natural traditional Chinese medicine (TCM) with an emphasis on environmentally friendly high-tech processes. Established in 1994, the enterprise was originally part of the publicly traded company Hainan Zhongtung High-Tech Materials Co., Ltd.

Tags

Skin and Musculoskeletal Diseases

Infectious Diseases

Urogenital Diseases

Small molecule drug

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Technology Platform

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Targets

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Disease Domain	Count

Infectious Diseases	1

Top 5 Drug Type	Count

Small molecule drug	1

Top 5 Target	Count

PP2A(Protein phosphatase 2A)	1

主要目的：以利多卡因的体内药代动力学参数（Cmax与AUC）为生物等效性的评价指标，在中国健康受试者外用条件下评估受试制剂（海南回元堂药业有限公司生产的利多卡因凝胶贴膏，规格5%）和参比制剂（Teikoku Seiyaku Co., Ltd.生产的利多卡因凝胶贴膏，规格5%，商品名：Lidoderm®）的生物等效性；以利多卡因的平均黏附力得分为非劣效的评价指标，在中国健康受试者外用条件下评估受试制剂和参比制剂的非劣效性。次要目的：观察中国健康受试者外用条件下受试制剂和参比制剂的皮肤刺激性和安全性。

[Translation]

Primary objective: To evaluate the bioequivalence of the test preparation (lidocaine gel patch produced by Hainan Huiyuantang Pharmaceutical Co., Ltd., specification 5%) and the reference preparation (lidocaine gel patch produced by Teikoku Seiyaku Co., Ltd., specification 5%, trade name: Lidoderm®) under the condition of topical use in Chinese healthy subjects, using the in vivo pharmacokinetic parameters (Cmax and AUC) of lidocaine as the evaluation indicators of bioequivalence; to evaluate the non-inferiority of the test preparation and the reference preparation under the condition of topical use in Chinese healthy subjects, using the average adhesion score of lidocaine as the evaluation indicator of non-inferiority. Secondary objective: To observe the skin irritation and safety of the test preparation and the reference preparation under the condition of topical use in Chinese healthy subjects.

Start Date28 Jul 2022

Sponsor / Collaborator

Hainan Huiyuantang Pharmaceutical Co Ltd

CTR20182203 / CompletedPhase 3

评价利多卡因凝胶膏治疗带状疱疹后神经痛有效性和安全性的随机、双盲、安慰剂平行对照、多中心临床试验

[Translation] A randomized, double-blind, placebo-controlled, multicenter clinical trial to evaluate the efficacy and safety of lidocaine gel in the treatment of postherpetic neuralgia

以安慰剂为对照，评价利多卡因凝胶膏治疗带状疱疹后神经痛的有效性和安全性

[Translation]

To evaluate the efficacy and safety of lidocaine gel in the treatment of postherpetic neuralgia compared with placebo

Start Date02 Jan 2019

Sponsor / Collaborator

Hainan Huiyuantang Pharmaceutical Co Ltd

100 Clinical Results associated with Hainan Huiyuantang Pharmaceutical Co Ltd

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0 Patents (Medical) associated with Hainan Huiyuantang Pharmaceutical Co Ltd

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1

Literatures (Medical) associated with Hainan Huiyuantang Pharmaceutical Co Ltd

Bioequivalence study of two lidocaine patches formulation in healthy Chinese subjects: the randomized, single-center, open-label, single-dose, 2-way 2-period crossover study

Author: Yan, Zhidong ; Wang, Hongdan ; Xu, Lang ; He, Xiaoai ; Peng, Hui ; Wang, Junlong ; Tong, Mei ; Ni, Na ; Wang, Liu ; Zhu, Gangzhi ; Kang, Xiaofei ; Han, Shengnan

AbstractBackground: (1) To evaluate the bioequivalence between test and reference formulations of lidocaine patches and to assess their pharmacokinetic (PK, Cmax and AUC) in healthy Chinese subjects. (2) To evaluate the noninferiority between test and reference formulations of lidocaine patches and to assess their average adhesion score in healthy Chinese subjects. (3) To evaluate the skin irritation and safety between test and reference formulations of lidocaine patches in healthy Chinese subjects. Method:A randomized, single-center, open-label, single-dose, 2-way 2-period crossover study was conducted in healthy Chinese subjects. Test lidocaine patches (T, continuous application for 12h with 3 dosage units) or reference lidocaine patches (R) were randomly given to subjects with an administration sequence of T-R, or R-T, while each single administration was followed by a 3-day washout period. The plasma concertation and corresponding PK parameters of lidocaine were calculated using the non-compartment model of Phoenix WinNonlin8.2. Bioequivalence, adhesion score and safety were analyzed by SAS9.4. Results:A total of 30 subjects were randomized and 29 subjects completed with the samples collected. The 90% CI and the GM ratio for Cmax, AUC0-t and AUC0-∞, respectively, were 108.07% (101.29%, 115.29%), 105.27% (99.85%, 110.98%), and 105.16% (99.77%, 110.83%) within the range of 80-125%. Adhesion scores were 0 under all period evaluated as noninferiority, and skin irritation was showing no difference between T and R. The incidence of AEs and drug-related AEs were similar between T and R (p＞0.05) and no serious AE occurred during the study. Conclusions: T and R were bioequivalent, well tolerated, and no difference in adhesion and skin irritation.

100 Deals associated with Hainan Huiyuantang Pharmaceutical Co Ltd

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100 Translational Medicine associated with Hainan Huiyuantang Pharmaceutical Co Ltd

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Pipeline

Pipeline Snapshot as of 05 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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