Delving into the Latest Updates on Hefei Huafang Medicine Technology Co., Ltd. with Synapse

Overview

Tags

Otorhinolaryngologic Diseases

Nervous System Diseases

Congenital Disorders

Small molecule drug

Disease domain score

A glimpse into the focused therapeutic areas

Technology Platform

Most used technologies in drug development

Targets

Most frequently developed targets

Disease Domain	Count

Endocrinology and Metabolic Disease	1
Infectious Diseases	1
Immune System Diseases	1
Nervous System Diseases	1

Top 5 Drug Type	Count

Small molecule drug	1

Top 5 Target	Count

SCNA(Sodium voltage-gated channel alpha subunits)	1

主要试验目的：以合肥华方医药科技有限公司持有的甲磺酸多沙唑嗪缓释片为受试制剂，以持证商为Pfizer Pharma PFE GmbH的甲磺酸多沙唑嗪缓释片（商品名：可多华®）为参比制剂，按生物等效性试验的相关规定，比较两种制剂在中国健康受试者体内的药代动力学行为，评价两种制剂的生物等效性。次要试验目的：评价中国健康受试者单次空腹口服受试制剂和参比制剂后的安全性。

[Translation]

The main purpose of the study is to use the doxazosin mesylate sustained-release tablets owned by Hefei Huafang Pharmaceutical Technology Co., Ltd. as the test preparation and the doxazosin mesylate sustained-release tablets (trade name: Kadova®) owned by Pfizer Pharma PFE GmbH as the reference preparation. According to the relevant provisions of the bioequivalence test, the pharmacokinetic behavior of the two preparations in healthy Chinese subjects is compared to evaluate the bioequivalence of the two preparations. Secondary purpose of the study: To evaluate the safety of the test preparation and the reference preparation after a single oral administration on an empty stomach in healthy Chinese subjects.

Start Date08 Jun 2024

Sponsor / Collaborator

Hefei Huafang Medicine Technology Co., Ltd.

CTR20233719

/ CompletedNot Applicable

帕利哌酮缓释片在健康受试者中单中心、随机、开放、单次给药、两制剂、两周期、双交叉的餐后状态下生物等效性试验

[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-period, double-crossover bioequivalence study of paliperidone extended-release tablets in healthy subjects under the fed state

主要试验目的：以合肥华方医药科技有限公司提供的帕利哌酮缓释片（规格：6 mg）为受试制剂，以Janssen Cilag Manufacturing L.L.C.生产的帕利哌酮缓释片（商品名：芮达®，规格：6 mg）为参比制剂，按生物等效性试验的相关规定，比较在中国健康受试者体内的药代动力学行为，评价两种制剂的生物等效性。次要试验目的：评价中国健康受试者单次餐后口服受试制剂和参比制剂后的安全性。

[Translation]

The main purpose of the study was to use the paliperidone extended-release tablets (specification: 6 mg) provided by Hefei Huafang Pharmaceutical Technology Co., Ltd. as the test preparation and the paliperidone extended-release tablets (trade name: Ruida®, specification: 6 mg) produced by Janssen Cilag Manufacturing L.L.C. as the reference preparation. According to the relevant provisions of the bioequivalence test, the pharmacokinetic behavior in healthy Chinese subjects was compared to evaluate the bioequivalence of the two preparations. Secondary purpose of the study was to evaluate the safety of the test preparation and the reference preparation after a single oral administration after a meal in healthy Chinese subjects.

Start Date13 Jan 2024

Sponsor / Collaborator

Hefei Huafang Medicine Technology Co., Ltd.

CTR20233442

/ CompletedNot Applicable

枸橼酸托法替布缓释片在健康受试者中单中心、随机、开放、单次给药、两制剂、两周期、双交叉的空腹状态下生物等效性试验

[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-period, double-crossover bioequivalence study of tofacitinib citrate extended-release tablets in healthy subjects under fasting conditions

主要试验目的：以合肥华方医药科技有限公司提供的枸橼酸托法替布缓释片（规格：11 mg）为受试制剂，以Pfizer Inc.持有的枸橼酸托法替布缓释片（商品名：尚杰®，规格：11 mg）为参比制剂，按生物等效性试验的相关规定，比较在中国健康受试者体内的药代动力学行为，评价两种制剂的生物等效性。次要试验目的：评价中国健康受试者单次空腹口服受试制剂和参比制剂后的安全性。

[Translation]

The main purpose of the study is to use the tofacitinib citrate sustained-release tablets (specification: 11 mg) provided by Hefei Huafang Pharmaceutical Technology Co., Ltd. as the test preparation and the tofacitinib citrate sustained-release tablets (trade name: Shangjie®, specification: 11 mg) held by Pfizer Inc. as the reference preparation. According to the relevant provisions of the bioequivalence test, the pharmacokinetic behavior in healthy Chinese subjects is compared to evaluate the bioequivalence of the two preparations. Secondary purpose of the study: To evaluate the safety of the test preparation and the reference preparation after a single oral administration on an empty stomach in healthy Chinese subjects.

Start Date03 Jan 2024

Sponsor / Collaborator

Hefei Huafang Medicine Technology Co., Ltd.

100 Clinical Results associated with Hefei Huafang Medicine Technology Co., Ltd.

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0 Patents (Medical) associated with Hefei Huafang Medicine Technology Co., Ltd.

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100 Deals associated with Hefei Huafang Medicine Technology Co., Ltd.

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100 Translational Medicine associated with Hefei Huafang Medicine Technology Co., Ltd.

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Pipeline

Pipeline Snapshot as of 24 Jan 2025

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

IND Application

1

IND Approval

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