Juan Jin, Chunrong Huang, Fangliang Gan, Tuo Li, Lina Wang, Xiaolu Wang, Xiali Rao, Jufang Liu
{"title":"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。","authors":"Juan Jin, Chunrong Huang, Fangliang Gan, Tuo Li, Lina Wang, Xiaolu Wang, Xiali Rao, Jufang Liu","doi":"10.1002/cpdd.1564","DOIUrl":null,"url":null,"abstract":"<p><p>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.</p>","PeriodicalId":10495,"journal":{"name":"Clinical Pharmacology in Drug Development","volume":" ","pages":""},"PeriodicalIF":1.8000,"publicationDate":"2025-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Pharmacokinetics, Bioequivalence, and Safety of Levothyroxine Sodium Tablets in Healthy Chinese Subjects.\",\"authors\":\"Juan Jin, Chunrong Huang, Fangliang Gan, Tuo Li, Lina Wang, Xiaolu Wang, Xiali Rao, Jufang Liu\",\"doi\":\"10.1002/cpdd.1564\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>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.</p>\",\"PeriodicalId\":10495,\"journal\":{\"name\":\"Clinical Pharmacology in Drug Development\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":1.8000,\"publicationDate\":\"2025-07-31\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical Pharmacology in Drug Development\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1002/cpdd.1564\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical Pharmacology in Drug Development","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1002/cpdd.1564","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
Pharmacokinetics, Bioequivalence, and Safety of Levothyroxine Sodium Tablets in Healthy Chinese Subjects.
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.
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.