Pharmacokinetics, Bioequivalence, and Safety of Levothyroxine Sodium Tablets in Healthy Chinese Subjects.

IF 1.8 4区 医学 Q3 PHARMACOLOGY & PHARMACY
Juan Jin, Chunrong Huang, Fangliang Gan, Tuo Li, Lina Wang, Xiaolu Wang, Xiali Rao, Jufang Liu
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引用次数: 0

Abstract

Recently, a local pharmaceutical company produced levothyroxine sodium tablets, an endogenous drug that helps improve water-salt metabolism and reduce myxedema. However, the bioequivalence of these tablets is not well known. The present study aimed to investigate the bioequivalence, pharmacokinetics, and safety of a single oral dose of 2 levothyroxine sodium tablets in healthy adult Chinese subjects under fasting conditions. The study used a single-center randomized, single-dose, 2-sequence, 4-period replicate crossover design. Forty-eight subjects fasted for at least 10 hours before taking the medication. According to the literature, levothyroxine sodium is an endogenous narrow therapeutic index drug; therefore, baseline samples were collected before administration in healthy adult subjects. Blood specimens from all subjects were collected against the light within 48 hours to detect levothyroxine concentration in serum. A noncompartmental model was used for the analysis of pre- and post-baseline correction pharmacokinetic parameters. The geometric mean ratio of the post-baseline correction maximum plasma concentration and area under the concentration-time curve from time 0 to 48 hours with a 90% confidence interval was calculated. The final data met the bioequivalence criteria. No serious adverse reactions were found, suggesting that the test and reference preparations of levothyroxine sodium tablets have a similar safety profile.

左旋甲状腺素钠片在健康人体内的药动学、生物等效性和安全性。
最近,当地一家制药公司生产了左甲状腺素钠片,这是一种内源性药物,有助于改善水盐代谢,减少黏液水肿。然而,这些片剂的生物等效性尚不清楚。本研究旨在探讨单剂量左甲状腺素钠片在中国健康成人空腹条件下的生物等效性、药代动力学和安全性。本研究采用单中心随机、单剂量、2序列、4期重复交叉设计。48名受试者在服药前禁食至少10小时。据文献报道,左甲状腺素钠是一种内源性窄治疗指数药物;因此,在健康成人受试者给药前收集基线样本。所有受试者于48小时内光照下采集血样,检测血清中左甲状腺素浓度。非室室模型用于分析基线前后校正药代动力学参数。计算基线校正后最大血浆浓度与浓度-时间曲线下面积在0 ~ 48小时的几何平均比值,置信区间为90%。最终数据符合生物等效性标准。未发现严重不良反应,提示左甲状腺素钠片的试验制剂和参比制剂具有相似的安全性。
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
CiteScore
3.70
自引率
10.00%
发文量
154
期刊介绍: Clinical Pharmacology in Drug Development is an international, peer-reviewed, online publication focused on publishing high-quality clinical pharmacology studies in drug development which are primarily (but not exclusively) performed in early development phases in healthy subjects.
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