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Comparative, Single-Dose, 2-Way Cross-Over Bioavailability Study of Two Olanzapine 10 Mg Tablet Formulations in Healthy Volunteers Under Fasting Conditions Cover

Comparative, Single-Dose, 2-Way Cross-Over Bioavailability Study of Two Olanzapine 10 Mg Tablet Formulations in Healthy Volunteers Under Fasting Conditions

Open Access
|Jul 2022

References

  1. 1. Smith RC, Leucht S, Davis JM. Maximizing response to first-line antipsychotics in schizophrenia: a review focused on finding from meta-analysis. Psychopharmacology (Berl) 2019;236(2):545-59. doi:10.1007/s00213-018-5133-z
  2. 2. Meftah AM, Deckler E, Citrome L, Kantrowitz JT. New discoveries for an old drug: a review of recent Olanzapine research. Postgrad Med 2020;132(1):80-90. doi:10.1080/00325481.2019.1701823
  3. 3. Kantrowitz JT, Citrome L. Olanzapine: review of safety 2008. Expert Opin Drug Saf 2008;7(6):761-9. doi:10.1517/14740330802423234
  4. 4. McCormack PL, Wiseman LR. Olanzapine: a review of its use in the management of bipolar I disorder. Drugs 2004;64(23):2709-26. doi:10.2165/00003495-200464230-00006
  5. 5. Leucht S, Cipriani A, Spineli L, et al. Comparative efficacy and tolerability of 15 antipsychotic drugs in schizophrenia: a multiple-treatments meta-analysis. Lancet 2013;382(9896):951-62. doi:10.1016/S0140-6736(13)60733-3
  6. 6. Callaghan JT, Bergstrom RF, Ptak LR, Beasley CM. Olanzapine. Pharmacokinetic and pharmacodynamic profile. Clin Pharmacokinet 1999;37(3):177-93. doi:10.2165/00003088-199937030-00001.10511917
  7. 7. Zyprexa Summary of Product Characteristics [Internet]. European Medicines Agency. Available from: https://www.ema.europa.eu/en/documents/product-information/zyprexa-epar-product-information_en.pdf
  8. 8. EMEA/CPMP/EWP/QWP/1401/98. Note for Guidance on the Investigation of Bioavailability and Bioequivalence. London, January 2002.
  9. 9. EMEA/CPMP/ICH/135/95. ICH Topic E6: Note for Guidance on Good Clinical Practice. London, January 1997.
  10. 10. Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Official Journal L 121, 01/05/2001 P. 0034 - 0044.
  11. 11. WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subject. Available from: https://www.wma.net/wp-content/uploads/2016/11/DoH-Oct2008.pdf.
  12. 12. Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm 1987;15(6):657-80. doi:10.1007/BF01068419.3450848
  13. 13. Diletti E, Hauschke D, Steinijans VW. Sample size determination for bioequivalence assessment by means of confidence intervals. Int J Clin Pharmacol Ther Toxicol 1991;29(1):1-8.
  14. 14. Hauschke D, Steinijans WV, Diletti E, et al. Presentation of the intrasubject coefficient of variation for sample size planning in bio-equivalence studies. Int J Clin Pharmacol Ther 1994;32(7):376-8.
  15. 15. Himmerich H, Au K, Dornik J, Bentley J, Schmidt U, Treasure J. Olanzapine Treatment for Patients with Anorexia Nervosa. Can J Psychiatry 2017;62(7):506-7. doi:10.1177/0706743717709967.552899028683226
  16. 16. Davis LE, Attia E. Recent advances in therapies for eating disorders. F1000Res. 2019 26;8:F1000 Faculty Rev-1693. doi: 10.12688/f1000research.19847.1.676411631598212
  17. 17. Sutherland A, Naessens K, Plugge E, et al. Olanzapine for the prevention and treatment of cancer-related nausea and vomiting in adults. Co-chrane Database Syst Rev 2018;9(9):CD012555. doi:10.1002/14651858.CD012555.pub2.651343730246876
  18. 18. Yang T, Liu Q, Lu M, Ma L, Zhou Y, Cui Y. Efficacy of Olanzapine for the prophylaxis of chemotherapy-induced nausea and vomiting: a meta-analysis. Br J Clin Pharmacol 2017;83(7):1369-79. doi:10.1111/bcp.13242.546534528112422
  19. 19. Tanaka K, Inui N, Karayama M, et al. Olanzapine-containing antiemetic therapy for the prevention of carboplatin-induced nausea and vomiting. Cancer Chemother Pharmacol 2019;84(1):147-53. doi:10.1007/s00280-019-03868-5.31087137
  20. 20. Du P, Li P, Liu H, Zhao R, Zhao Z, Yu W, et al. Open-Label, Randomized, Single-Dose, 2-Period, 2-Sequence Crossover, Comparative Pharmacokinetic Study to Evaluate Bioequivalence of 2 Oral Formulations of Olanzapine Under Fasting and Fed Conditions. Clin Pharmacol Drug Dev 2020;9(5):621-628. doi: 10.1002/cpdd.743.31595704
  21. 21. Chen Q, Zhang MQ, Liu Y, et al. Pharmacokinetics and bioequivalence of 2 tablet formulations of Olanzapine in healthy Chinese volunteers: a randomized, open-label, single-dose study. Arzneimittelforschung 2012;62(11):508-12. doi:10.1055/s-0032-1323659.22933048
  22. 22. Cánovas M, Torres F, Domenech G, Cebrecos J, Pelagio P, Manríquez M, et al. Bioequivalence evaluation of two dosage forms of Olanzapine 10 mg formulations in healthy volunteers. Arzneimittelforschung 2011;61(2):75-9. doi: 10.1055/s-0031-1296170.21428240
  23. 23. Elshafeey AH, Elsherbiny MA, Fathallah MM. A single-dose, randomized, two-way crossover study comparing two Olanzapine tablet products in healthy adult male volunteers under fasting conditions. Clin Ther 2009;31(3):600-8. doi:10.1016/j.clinthera.2009.03.008.19393850
  24. 24. Singhal R, Thakkar V, Srivastava A. Evaluation of bioequivalence of two oral formulations of Olanzapine. Indian J Pharm Sci 2011;73(6):678-682. doi:10.4103/0250-474X.100249.348075623112405
DOI: https://doi.org/10.2478/prilozi-2022-0026 | Journal eISSN: 1857-8985 | Journal ISSN: 1857-9345
Language: English
Page range: 135 - 143
Published on: Jul 13, 2022
Published by: Macedonian Academy of Sciences and Arts
In partnership with: Paradigm Publishing Services
Publication frequency: 2 issues per year

© 2022 Emilija Atanasovska, Krume Jakjovski, Kristina Pavlovska, Kalina Gjorgjievska, Dimche Zafirov, Dragica Zendelovska, Marija Petrushevska, Nikola Labachevski, published by Macedonian Academy of Sciences and Arts
This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.