空腹条件下两种复方新诺明片剂在中国健康志愿者中的药代动力学和生物等效性评价。

IF 2.8 3区 医学 Q2 PHARMACOLOGY & PHARMACY
Xu Zuo, Xin Zhao, Jinjin Shi, Tiandong Zhang
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引用次数: 0

摘要

本生物等效性研究旨在评估复方新诺明片剂在中国健康受试者中的两种口服制剂的生物等效性。所有 26 名受试者被随机平均分为两组,分别服用单剂量(磺胺甲噁唑:400 毫克,曲美布林:80 毫克)的试验复方新诺明片(仿制药)或参比复方新诺明片(品牌药)。经过 7 天的冲洗期后,这些受试者再服用一剂参比药物或试验药物。研究人员在用药前和用药后 48 小时内采集血样,以评估血浆中磺胺甲噁唑(SMX)和三甲氧苄啶(TMP)的浓度,并绘制血浆浓度-时间曲线。然后,相应地计算药代动力学参数。我们的数据显示,两种制剂的最大血浆浓度(Cmax)、从时间 0 到最后可测量浓度的曲线下面积(AUC0-t)以及从时间 0 到无穷大的曲线下面积(AUC0-∞)均无明显差异。对于 SMX,Cmax、AUC0-t 和 AUC0-∞ 的几何平均比值的 90% 置信区间(CI)分别为 104.03-113.92%、100.46-103.70% 和 100.41-103.81%。同样,对于三甲氧苄啶(TMP),Cmax 的 90% CI 为 98.54%-106.95%,AUC0-t 为 99.31%-107.68%,AUC0-∞ 为 99.49%-107.55%。重要的是,所有这些 90% CI 值都在 80.00-125.00% 的范围内,表明试验药物与参比药物具有生物等效性。此外,在整个试验过程中,没有出现疑似严重不良事件的报告,这表明新开发的复方新诺明仿制药具有良好的安全性。总之,我们的研究表明,在空腹条件下,新开发的复方新诺明非专利制剂与品牌制剂具有生物等效性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Pharmacokinetics and bioequivalence evaluation of two oral formulations of cotrimoxazole tablets in healthy Chinese volunteers under fasting conditions.

This bioequivalence study was conducted to evaluate two oral formulations of cotrimoxazole tablets in healthy Chinese subjects. All 26 subjects recruited to this study were randomly and evenly classified into two groups and received a single dose (sulfamethoxazole: 400 mg and trimethoprim: 80 mg) of test cotrimoxazole tablets (generic drug) or reference cotrimoxazole tablets (branded drug). After a 7-day washout period, these subjects received one dose of reference drug or test drug. Blood samples were collected from participants before and up to 48 h after dosing to assess the concentration of sulfamethoxazole (SMX) and trimethoprim (TMP) in plasma and a plasma concentration-time curve was drawn. Then, the pharmacokinetics parameters were calculated accordingly. Our data revealed that there were no significant differences observed in the maximum plasma concentration (Cmax), area under the curve from time 0 to the last measurable concentration (AUC0-t), and area under the curve from time 0 to infinity (AUC0-∞) between the two formulations. For SMX, the 90% confidence intervals (CI) of the geometric mean ratio for Cmax, AUC0-t, and AUC0-∞ were 104.03-113.92%, 100.46-103.70%, and 100.41-103.81%, respectively. Similarly, for Trimethoprim (TMP), the 90% CI ranged from 98.54 to 106.95% for Cmax, from 99.31 to 107.68% for AUC0-t, and from 99.49 to 107.55% for AUC0-∞. Importantly, all these 90% CI values fell within the range of 80.00-125.00%, indicating that the test drug is bioequivalent to the reference drug. Furthermore, throughout the entire trial, no suspected serious adverse events were reported, indicating the safety profile of the newly developed generic cotrimoxazole. In summary, our study demonstrates that the newly developed generic formulation of cotrimoxazole is bioequivalent to the branded formulation under fasting conditions.

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来源期刊
BMC Pharmacology & Toxicology
BMC Pharmacology & Toxicology PHARMACOLOGY & PHARMACYTOXICOLOGY&nb-TOXICOLOGY
CiteScore
4.80
自引率
0.00%
发文量
87
审稿时长
12 weeks
期刊介绍: BMC Pharmacology and Toxicology is an open access, peer-reviewed journal that considers articles on all aspects of chemically defined therapeutic and toxic agents. The journal welcomes submissions from all fields of experimental and clinical pharmacology including clinical trials and toxicology.
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