Delving into the Latest Updates on Henan Taifeng Biotechnology Co., Ltd. with Synapse

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Respiratory Diseases

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30S subunit x 50S subunit	1

[Translation] A single-center, randomized, open-label, single-dose, four-cycle, two-sequence, fully repeated crossover bioequivalence study to evaluate the test preparation Dydrogesterone Tablets (strength: 10 mg) and the reference preparation Daphaston® (strength: 10 mg) in healthy adult subjects in the fed state

主要研究目的：研究餐后状态下单次口服受试制剂地屈孕酮片（规格：10 mg，持证商：河南泰丰生物科技有限公司）与参比制剂地屈孕酮片（达芙通®，规格：10 mg，持证商：Abbott B.V.）在健康成年女性受试者体内的药代动力学，评价餐后状态口服两种制剂的生物等效性。次要研究目的：评估受试制剂地屈孕酮片（规格：10 mg）和参比制剂地屈孕酮片（达芙通®，规格：10 mg）在健康成年女性受试者中的安全性。

[Translation]

The main purpose of the study is to study the pharmacokinetics of the test preparation Dydrogesterone Tablets (Specification: 10 mg, licensee: Henan Taifeng Biotechnology Co., Ltd.) and the reference preparation Dydrogesterone Tablets (Duphaston®, Specification: 10 mg, licensee: Abbott B.V.) in healthy adult female subjects after a single oral administration in the fed state, and to evaluate the bioequivalence of the two preparations after oral administration in the fed state. The secondary purpose of the study is to evaluate the safety of the test preparation Dydrogesterone Tablets (Specification: 10 mg) and the reference preparation Dydrogesterone Tablets (Duphaston®, Specification: 10 mg) in healthy adult female subjects.

Start Date10 Nov 2024

Sponsor / Collaborator

Henan Taifeng Biotechnology Co., Ltd.

CTR20242246

/ CompletedNot Applicable

评估受试制剂地屈孕酮片(规格:10mg)与参比制剂达芙通(规格:10mg)在健康成年受试者空腹和餐后状态下的单中心、随机、开放、单剂量、四周期、两序列、完全重复交叉生物等效性研究

[Translation] A single-center, randomized, open-label, single-dose, four-cycle, two-sequence, fully repeated crossover bioequivalence study was conducted to evaluate the bioequivalence of the test preparation Dydrogesterone Tablets (10 mg) and the reference preparation Daphaston (10 mg) in healthy adult subjects in the fasting and fed state.

主要研究目的：研究空腹和餐后状态下单次口服受试制剂地屈孕酮片（规格：10 mg，持证商：河南泰丰生物科技有限公司）与参比制剂地屈孕酮片（达芙通®，规格：10 mg，持证商：Abbott B.V.）在健康成年女性受试者体内的药代动力学，评价空腹和餐后状态口服两种制剂的生物等效性。次要研究目的：评估受试制剂地屈孕酮片（规格：10 mg）和参比制剂地屈孕酮片（达芙通®，规格：10 mg）在健康成年女性受试者中的安全性。

[Translation]

The main purpose of the study is to study the pharmacokinetics of the test preparation Dydrogesterone Tablets (Specification: 10 mg, licensee: Henan Taifeng Biotechnology Co., Ltd.) and the reference preparation Dydrogesterone Tablets (Duphaston®, Specification: 10 mg, licensee: Abbott B.V.) in healthy adult female subjects after a single oral administration in the fasting and fed state, and to evaluate the bioequivalence of the two preparations in the fasting and fed state. Secondary purpose of the study is to evaluate the safety of the test preparation Dydrogesterone Tablets (Specification: 10 mg) and the reference preparation Dydrogesterone Tablets (Duphaston®, Specification: 10 mg) in healthy adult female subjects.

Start Date19 Jul 2024

Sponsor / Collaborator

Henan Taifeng Biotechnology Co., Ltd.

CTR20240415

/ CompletedNot Applicable

评估受试制剂盐酸帕洛诺司琼软胶囊（规格：0.5 mg）与参比制剂Aloxi®（规格：0.5 mg）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 bioequivalence of the test formulation, palonosetron hydrochloride soft capsules (strength: 0.5 mg), and the reference formulation, Aloxi® (strength: 0.5 mg), in healthy adult subjects in the fasting and fed state.

主要研究目的：评估空腹和餐后状态下单次口服受试制剂盐酸帕洛诺司琼软胶囊（规格：0.5 mg，持证商：河南泰丰生物科技有限公司）与参比制剂盐酸帕洛诺司琼软胶囊（Aloxi®，规格：0.5 mg，持证商：Helsinn Birex Pharmaceuticals Ltd.）在健康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。次要研究目的：评估受试制剂盐酸帕洛诺司琼软胶囊（规格：0.5 mg）与参比制剂盐酸帕洛诺司琼软胶囊（Aloxi®，规格：0.5 mg）在健康受试者中的安全性。

[Translation]

The main purpose of the study is to evaluate the pharmacokinetic characteristics of the test preparation Palonosetron Hydrochloride Soft Capsules (Specification: 0.5 mg, licensee: Henan Taifeng Biotechnology Co., Ltd.) and the reference preparation Palonosetron Hydrochloride Soft Capsules (Aloxi®, Specification: 0.5 mg, licensee: Helsinn Birex Pharmaceuticals Ltd.) in healthy subjects after a single oral administration in the fasting and fed state, and to evaluate the bioequivalence of the two preparations after oral administration in the fasting and fed state. Secondary purpose of the study is to evaluate the safety of the test preparation Palonosetron Hydrochloride Soft Capsules (Specification: 0.5 mg) and the reference preparation Palonosetron Hydrochloride Soft Capsules (Aloxi®, Specification: 0.5 mg) in healthy subjects.

Start Date13 Mar 2024

Sponsor / Collaborator

Henan Taifeng Biotechnology Co., Ltd.

100 Clinical Results associated with Henan Taifeng Biotechnology Co., Ltd.

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0 Patents (Medical) associated with Henan Taifeng Biotechnology Co., Ltd.

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100 Deals associated with Henan Taifeng Biotechnology Co., Ltd.

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100 Translational Medicine associated with Henan Taifeng Biotechnology Co., Ltd.

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Pipeline

Pipeline Snapshot as of 07 Aug 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

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