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Pharmacokinetic and pharmacodynamic evaluation study of etomidate: a randomized, open-label, 2-period crossover study in healthy Chinese subjects.

التفاصيل البيبلوغرافية
العنوان: Pharmacokinetic and pharmacodynamic evaluation study of etomidate: a randomized, open-label, 2-period crossover study in healthy Chinese subjects.
المؤلفون: Ding Y; Drug Clinical Trial Institution, Wuxi People's Hospital Affiliated with Nanjing Medical University, Wuxi, 214023, Jiangsu, China., Chu NN; Drug Clinical Trial Institution, Wuxi People's Hospital Affiliated with Nanjing Medical University, Wuxi, 214023, Jiangsu, China., Wang R; Jiangsu Nhwa Pharmaceutical CoLtd, Xuzhou, Jiangsu, China., Qin W; Drug Clinical Trial Institution, Wuxi People's Hospital Affiliated with Nanjing Medical University, Wuxi, 214023, Jiangsu, China., Shi YF; Drug Clinical Trial Institution, Wuxi People's Hospital Affiliated with Nanjing Medical University, Wuxi, 214023, Jiangsu, China., Qian ZZ; Drug Clinical Trial Institution, Wuxi People's Hospital Affiliated with Nanjing Medical University, Wuxi, 214023, Jiangsu, China., Liu B; Jiangsu Nhwa Pharmaceutical CoLtd, Xuzhou, Jiangsu, China., He Q; Drug Clinical Trial Institution, Wuxi People's Hospital Affiliated with Nanjing Medical University, Wuxi, 214023, Jiangsu, China. heqing0510@163.com.
المصدر: Scientific reports [Sci Rep] 2024 Mar 25; Vol. 14 (1), pp. 7071. Date of Electronic Publication: 2024 Mar 25.
نوع المنشور: Randomized Controlled Trial; Journal Article
اللغة: English
بيانات الدورية: Publisher: Nature Publishing Group Country of Publication: England NLM ID: 101563288 Publication Model: Electronic Cited Medium: Internet ISSN: 2045-2322 (Electronic) Linking ISSN: 20452322 NLM ISO Abbreviation: Sci Rep Subsets: MEDLINE
أسماء مطبوعة: Original Publication: London : Nature Publishing Group, copyright 2011-
مواضيع طبية MeSH: Etomidate*/pharmacokinetics , Etomidate*/pharmacology, Humans ; Area Under Curve ; China ; Cross-Over Studies ; Healthy Volunteers ; Hypnotics and Sedatives/pharmacokinetics ; Hypnotics and Sedatives/pharmacology ; Tablets ; Therapeutic Equivalency
مستخلص: Etomidate is a sedative and hypnotic drug through intravenous administration that act on the central nervous system through GABA (Gamma-Amino Butyric Acid) receptors, which is widely used in anesthesia induction and maintenance and long-term sedation in severe patients. The study aimed to evaluate the pharmacokinetic and pharmacodynamic properties of two etomidate fat emulsions after administration through the intravenous infusion pump in healthy Chinese subjects. A randomized, open-label, 2-period crossover study was performed in 52 healthy subjects. The wash-out period was 7 days. Blood samples and pharmacodynamic index values were collected at the specified time points. Etomidate concentrations were measured using validated liquid chromatography-tandem mass spectrometry. Pharmacokinetic parameters were analyzed using a non-compartment model method. Pharmacodynamic parameters were calculated using pharmacodynamic index values. The study also evaluated the safety of the etomidate. Both the pharmacokinetic parameters and pharmacodynamic parameters result of the test and reference formulation were very similar. The 90% confidence intervals (CI) of the geometric least-squares mean (GLSM) ratios of the test to reference formulation were 91.33-104.96% for the maximum plasma concentration (C max ), 97.21-102.03% for the area under the plasma concentration time curve from time 0 to the time of the last measurable concentration (AUC 0-t ), and 97.22-102.33% for the area under the plasma concentration time curve from time 0 to infinity (AUC 0-∞ ). Meanwhile, the 90% CI of the GLSM ratios of the test to reference formulation were 102.28-110.69% for the minimal BIS value (BIS min ), 99.23-101.17% for the area under the BIS time curve from time 0-60 min after administration (BISAUC 0-60 min ), respectively. The 90% CI of these pharmacokinetic and pharmacodynamic parameters all fall in the accepted bioequivalence range of 80.00-125.00%. No serious adverse events occurred during the study. This study has shown that the etomidate fat emulsion test and reference formulation had similar pharmacokinetic and pharmacodynamic characteristics in vivo. The two formulations exhibited good safety and well-tolerance.Clinical trials registration number: http://www.chinadrugtrials.org.cn/index.html . # CTR20191836.
(© 2024. The Author(s).)
References: J Clin Pharmacol. 2011 Apr;51(4):482-91. (PMID: 20498288)
Anesthesiology. 2011 Mar;114(3):695-707. (PMID: 21263301)
Anesthesiology. 1986 Jul;65(1):19-27. (PMID: 3729056)
Clin Pharmacokinet. 1979 Mar-Apr;4(2):144-8. (PMID: 455872)
المشرفين على المادة: Z22628B598 (Etomidate)
0 (Hypnotics and Sedatives)
0 (Tablets)
تواريخ الأحداث: Date Created: 20240326 Date Completed: 20240327 Latest Revision: 20240410
رمز التحديث: 20240411
مُعرف محوري في PubMed: PMC10963774
DOI: 10.1038/s41598-024-57581-2
PMID: 38528026
قاعدة البيانات: MEDLINE
الوصف
تدمد:2045-2322
DOI:10.1038/s41598-024-57581-2