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Overview

本试验旨在研究单次空腹和餐后口服广州朗圣药业有限公司研制、生产的地屈孕酮片（10 mg）的药代动力学特征；以Abbott Biologicals B.V.生产的地屈孕酮片（达芙通®，10 mg）为参比制剂，比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞，评价两制剂的人体生物等效性。

[Translation]

This study aimed to investigate the pharmacokinetic characteristics of dydrogesterone tablets (10 mg) developed and produced by Guangzhou Langsheng Pharmaceutical Co., Ltd. after single oral administration on an empty stomach or after a meal. Using dydrogesterone tablets (Duphaston®, 10 mg) produced by Abbott Biologicals B.V. as the reference preparation, the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared to evaluate the bioequivalence of the two preparations in humans.

Start Date18 Jul 2024

Sponsor / Collaborator

Regenex Corp.

CTR20240529

/ CompletedNot Applicable

屈螺酮炔雌醇片在空腹及餐后条件下的人体生物等效性试验

[Translation] Bioequivalence study of drospirenone and ethinyl estradiol tablets in humans under fasting and fed conditions

本研究考察健康女性受试者在空腹及餐后条件下，单次口服由广州朗圣药业有限公司提供的屈螺酮炔雌醇片（受试制剂，规格：3mg/0.03mg）与相同条件下单次口服由Jenapharm GmbH & Co. KG持证的屈螺酮炔雌醇片（参比制剂，商品名：Yasmin®，规格：3mg/0.03mg）的药动学特征，评价两制剂间的生物等效性及安全性，为该受试制剂的注册申请提供依据。

[Translation]

This study investigated the pharmacokinetic characteristics of drospirenone ethinyl estradiol tablets (test preparation, specification: 3mg/0.03mg) provided by Guangzhou Langsheng Pharmaceutical Co., Ltd. and drospirenone ethinyl estradiol tablets (reference preparation, trade name: Yasmin®, specification: 3mg/0.03mg) certified by Jenapharm GmbH & Co. KG in healthy female subjects under fasting and postprandial conditions, and evaluated the bioequivalence and safety of the two preparations to provide a basis for the registration application of the test preparation.

Start Date27 Feb 2024

Sponsor / Collaborator

Regenex Corp.

CTR20230936

/ CompletedPhase 4

米索前列醇阴道片对足月妊娠妇女促宫颈成熟和引产有效性及安全性的多中心临床试验

[Translation] A multicenter clinical trial on the efficacy and safety of misoprostol vaginal tablets in promoting cervical ripening and inducing labor in term pregnant women

在大样本人群中观察米索前列醇阴道片（给药间隔6h）的安全性和有效性。

[Translation]

To observe the safety and efficacy of misoprostol vaginal tablets (dosing interval 6h) in a large sample population.

Start Date22 Aug 2023

Sponsor / Collaborator

Regenex Corp.

100 Clinical Results associated with Regenex Corp.

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0 Patents (Medical) associated with Regenex Corp.

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Literatures (Medical) associated with Regenex Corp.

Zhongguo Yaopin Biaozhun

Determination method for related substances of ulipristal acetate tablets

Author: Peng, Guizi ; Tao, Yan ; Xu, Shuo ; Lin, Shengwen ; Peng, Miao ; Huang, Heyi ; Zuo, Lian ; Zhang, Jin

Objective: To establish a method for determining related substances of Ulipristal Acetate Tablets.Methods: HPLC was adopted and the separated was performed on a C₁₈ column with a mixture of 0.01 mol·L^-1 potassium dihydrogen phosphate and acetonitrile (35:65) as mobile phase.The flow rate was 1.0 mL·min^-1 potassium dihydrogen phosphate and acetonitrile (35:65) as mobile phase.The flow rate was 1.0 mL·min^-1 and the detection wavelength was set at 304 nm.Results: The main peak of Ulipristal Acetate Tablets was well separated from degradation impurities.The main degradation impurity N-demethyluipristal acetate was identified and assayed.Conclusion: The newly established method can be used for quality control of Ulipristal Acetate Tablets.

100 Deals associated with Regenex Corp.

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100 Translational Medicine associated with Regenex Corp.

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Pipeline

Pipeline Snapshot as of 27 Apr 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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