A Single-Dose Pharmacokinetic and Bioequivalence Study of Generic and Original Aprepitant in Healthy Volunteers

Cover Page

Cite item

Full Text

Abstract

Chemotherapy-induced nausea and vomiting may lead to dehydration, malnutrition, and electrolyte imbalances, subsequently resulting in prolonged hospitalization and 
treatment refusal by patients. The addition of aprepitant to chemotherapy regimens in adult patients has demonstrated high efficacy in reducing emetogenic potential.

References

  1. Griffin A.M., Butow P.N., Coates A.S., et al. On the receiv ing end. V: Patient perceptions of the side effects of cancer chemotherapy in 1993. Ann Oncol Off J Eur Soc Med Oncol. 1996; 7(2): 189-95.-DOI: https://doi.org/10.1093/oxford journals.annonc.a010548
  2. Hesketh P.J., Rossi G., Rizzi G., et al. Efficacy and safety of NEPA, an oral combination of netupitant and palonosetron, for prevention of chemotherapy-induced nausea and vomit ing following highly emetogenic chemotherapy: a randomized dose-ranging pivotal study. Ann Oncol Off J Eur Soc Med Oncol. 2014; 25(7): 1340-6.-DOI: https://doi.org/10.1093/annonc/mdu110.
  3. Warr D.G., Hesketh P.J., Gralla R.J., et al. Efficacy and tol erability of aprepitant for the prevention of chemotherapy-in duced nausea and vomiting in patients with breast cancer after moderately emetogenic chemotherapy. J Clin Oncol Off J Am Soc Clin Oncol. 2005; 23(12): 2822-30.-DOI: https://doi.org/10.1200/JCO.2005.09.050.
  4. Руководство по экспертизе лекарственных средств. Т. 1. Москва: Гриф и К. 2014: 323. [Guide to drug examination, V. 1. Grif and K. 2014: 323 (In Rus)].
  5. Guideline on bioanalytical method validation (09 April 2025). European Medicines Agency, Committee for Me dicinal Products for Human Use (CHMP). 2012.-URL: https://www.ema.europa.eu/en/documents/scientif ic-guideline/guideline-bioanalytical-method-valida tion_en.pdf.
  6. Australian Government. Department of Health and Ageing. Therapeutic Goods Administration. Australian Public Assess ment Report for Aprepitant. 2012; 73.-URL: https://www.tga.gov.au/sites/default/files/auspar-aprepitant-121112.pdf.
  7. Hungary: National Institute of Pharmacy and Nutrition (OGYÉI). Public Assessment Report U/H/0624/001-003/DC. 2021; 22.-URL: https://ogyei.gov.hu/kiseroirat/ph/Aprepitant%20QPharma-PAReng.pdf.
  8. College ter Beoordeling van Geneesmiddelen (CBG). Pub lic Assessment Report NL/H/3854/001-003/DC. 2018; 12.-URL: https://www.geneesmiddeleninformatiebank.nl/pars/h121087.pdf.
  9. Hesketh P.J., et al. The oral neurokinin-1 antagonist aprepi tant for the prevention of chemotherapy-induced nausea and vomiting: a multinational, randomized, double-blind, pla cebo-controlled trial in patients receiving high-dose cispla tin--the Aprepitant Protocol 052 Study Group. J Clin Oncol Off J Am Soc Clin Oncol. 2003; 21(22): 4112-4119.-DOI: https://doi.org/10.1200/JCO.2003.01.095
  10. Warr D.G., et al. Efficacy and tolerability of aprepitant for the prevention of chemotherapy-induced nausea and vomiting in patients with breast cancer after moderately emetogen ic chemotherapy. J Clin Oncol Off J Am Soc Clin Oncol. 2005; 23(12): 2822-2830.-DOI: https://doi.org/10.1200/JCO.2005.09.050

Supplementary files

Supplementary Files
Action
1. JATS XML
Download

Copyright (c) 2025 Problems in Oncology

Согласие на обработку персональных данных

 

Используя сайт https://journals.rcsi.science, я (далее – «Пользователь» или «Субъект персональных данных») даю согласие на обработку персональных данных на этом сайте (текст Согласия) и на обработку персональных данных с помощью сервиса «Яндекс.Метрика» (текст Согласия).