Bioequivalence of Water-Soluble Progesterone Injection (GenSci070) in Healthy Chinese Postmenopausal Women Volunteers

IF 3.2 4区医学 Q2 PHARMACOLOGY & PHARMACY

Clinical therapeutics Pub Date : 2025-01-30 DOI:10.1016/j.clinthera.2024.12.015

Rong Song BS , Xue Wu MS , Liang Xin MS , Chan Sun BS , Yuzhou Gui PhD , Hongjie Qian PhD , Chen Yu BS , Qian Chen PhD , Tianhong Luo PhD , Ying Ding MD , Weiwei Gao PhD , Xiaoyan Zhu PhD , Jingying Jia MS

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引用次数: 0

Abstract

Purpose

To study the pharmacokinetic characteristics of progesterone (GenSci070) in healthy Chinese postmenopausal women volunteers and to evaluate the bioequivalence and safety of GenSci070 and reference formulation.

Methods

In this randomized, open-label, single-center, single-dose, 2-period, 2-sequence, 2-way crossover study, 50 postmenopausal healthy women were recruited and received a single subcutaneous injection of test (GenSci070) or reference formulation 25 mg, respectively. Plasma progesterone concentrations were measured using liquid chromatography–tandem mass spectrometry, and pharmacokinetic parameters were calculated by noncompartmental analysis method using Phoenix WinNonlin 8.3.1 software to evaluate the bioequivalence. The safety profile was evaluated by adverse events, physical examination, vital signs, laboratory tests, 12-lead ECG, etc.

Findings

The geometric mean ratios (90% CIs) for C_max, AUC_0–t, and AUC_0–∞ of the test and reference formulations were 92.70% (87.29%–98.44%), 96.26% (94.02%–98.55%), and 95.46% (93.27%–97.71%), respectively. They were all within the acceptable bioequivalence range of 80% to 125%. Thirty-one treatment-emergent adverse events occurred in 22 participants (44.0%) who received test formulation and 21 treatment-emergent adverse events occurred in 16 participants (32.0%) who received reference formulation, all events were mild.

Implications

The water-soluble progesterone injection (GenSci070) demonstrated bioequivalence to the marketed progesterone injection (Lubion) and exhibited a good safety profile in this study.

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水溶性黄体酮注射液（GenSci070）在中国健康绝经后妇女志愿者中的生物等效性

目的：研究孕酮（GenSci070）在中国健康绝经后妇女志愿者体内的药动学特征，评价GenSci070及参比制剂的生物等效性和安全性。方法：在这项随机、开放标签、单中心、单剂量、2期、2序列、2向交叉研究中，招募了50名绝经后健康女性，分别接受单次皮下注射试验（GenSci070）或参比制剂25mg。采用液相色谱-串联质谱法测定血浆孕酮浓度，采用Phoenix WinNonlin 8.3.1软件计算药动学参数，评价生物等效性。通过不良事件、体格检查、生命体征、实验室检查、12导联心电图等评估安全性。结果：检验方和参比方的Cmax、AUC0-t和AUC0-∞的几何平均比值（90% ci）分别为92.70%（87.29% ~ 98.44%）、96.26%（94.02% ~ 98.55%）和95.46%（93.27% ~ 97.71%）。均在80% ~ 125%的可接受生物等效性范围内。接受试验制剂的22名受试者（44.0%）发生31起治疗性不良事件，接受参考制剂的16名受试者（32.0%）发生21起治疗性不良事件，所有事件均为轻度。意义：水溶性黄体酮注射液（GenSci070）与市场上销售的黄体酮注射液（Lubion）具有生物等效性，并且在本研究中显示出良好的安全性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Clinical therapeutics 医学-药学

CiteScore

6.00

自引率

3.10%

发文量

154

审稿时长

9 weeks

期刊介绍： Clinical Therapeutics provides peer-reviewed, rapid publication of recent developments in drug and other therapies as well as in diagnostics, pharmacoeconomics, health policy, treatment outcomes, and innovations in drug and biologics research. In addition Clinical Therapeutics features updates on specific topics collated by expert Topic Editors. Clinical Therapeutics is read by a large international audience of scientists and clinicians in a variety of research, academic, and clinical practice settings. Articles are indexed by all major biomedical abstracting databases.