{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,13]],"date-time":"2026-07-13T21:41:07Z","timestamp":1783978867373,"version":"3.55.0"},"reference-count":23,"publisher":"Springer Science and Business Media LLC","issue":"4","license":[{"start":{"date-parts":[[2025,5,27]],"date-time":"2025-05-27T00:00:00Z","timestamp":1748304000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.springernature.com\/gp\/researchers\/text-and-data-mining"},{"start":{"date-parts":[[2025,5,27]],"date-time":"2025-05-27T00:00:00Z","timestamp":1748304000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/www.springernature.com\/gp\/researchers\/text-and-data-mining"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Eur J Drug Metab Pharmacokinet"],"published-print":{"date-parts":[[2025,7]]},"DOI":"10.1007\/s13318-025-00946-3","type":"journal-article","created":{"date-parts":[[2025,5,27]],"date-time":"2025-05-27T04:41:29Z","timestamp":1748320889000},"page":"319-325","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Bioequivalence and Safety of Bilastine 20 mg Administered in Three Eight-Hourly Dose Versus a Single Daily Dose: A Randomized Two-Treatment, Two-Period, Cross-Over Comparative Study"],"prefix":"10.1007","volume":"50","author":[{"ORCID":"https:\/\/orcid.org\/0009-0000-7432-7557","authenticated-orcid":false,"given":"Ekta","family":"Sinha","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3513-4944","authenticated-orcid":false,"given":"Sagar","family":"Bhagat","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4937-3188","authenticated-orcid":false,"given":"Saiprasad","family":"Patil","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1701-2115","authenticated-orcid":false,"given":"Rahul","family":"Kodgule","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-8161-4873","authenticated-orcid":false,"given":"Vinayak","family":"Modi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4346-9194","authenticated-orcid":false,"given":"Hanmant","family":"Barkate","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2025,5,27]]},"reference":[{"issue":"9","key":"946_CR1","doi-asserted-by":"publisher","first-page":"145","DOI":"10.1186\/1939-4551-1-9-145","volume":"1","author":"FE Simon","year":"2008","unstructured":"Simon FE, Simons KJ. H1 antihistamines: current status and future directions. World Allergy Organ J. 2008;1(9):145\u201355.","journal-title":"World Allergy Organ J"},{"issue":"7","key":"946_CR2","doi-asserted-by":"publisher","first-page":"1393","DOI":"10.1111\/all.13397","volume":"73","author":"T Zuberbier","year":"2018","unstructured":"Zuberbier T, Aberer W, Asero R, Abdul Latiff AH, Baker D, Ballmer-Weber B, et al. The EAACI\/GA2LEN\/EDF\/WAO guideline for the definition, classification, diagnosis and management of urticaria. Allergy: Eur J Allergy Clin Immunol. 2018;73(7):1393\u2013414.","journal-title":"Allergy: Eur J Allergy Clin Immunol"},{"issue":"3","key":"946_CR3","doi-asserted-by":"publisher","first-page":"466","DOI":"10.1016\/j.jaci.2010.06.047","volume":"126","author":"JL Broek","year":"2010","unstructured":"Broek JL, Bousquet J, Baena-Cagnani CE, Bonini S, Canonica GW, Casale TB, et al. Allergic rhinitis and its impact on asthma (ARIA) guidelines: 2010 revision. J Allergy Clin Immunol. 2010;126(3):466\u201376.","journal-title":"J Allergy Clin Immunol"},{"issue":"9","key":"946_CR4","doi-asserted-by":"publisher","first-page":"1102","DOI":"10.1111\/all.12235","volume":"68","author":"G Roberts","year":"2013","unstructured":"Roberts G, Xatzipsalti M, Borrego LM, Custovic A, Halken S, Hellings PW, et al. Paediatric rhinitis: position paper of the European Academy of Allergy and Clinical Immunology. Allergy. 2013;68(9):1102\u201316.","journal-title":"Allergy"},{"issue":"3","key":"946_CR5","doi-asserted-by":"publisher","first-page":"122","DOI":"10.1136\/archdischild-2013-304446","volume":"100","author":"R Fitzsimons","year":"2015","unstructured":"Fitzsimons R, Van Der Poel LA, Thornhill W, Du Toit G, Shah N, Brough HA. Antihistamine use in children. Arch Dis Child Educ Pract Ed. 2015;100(3):122\u201331.","journal-title":"Arch Dis Child Educ Pract Ed"},{"issue":"7","key":"946_CR6","doi-asserted-by":"publisher","first-page":"1393","DOI":"10.1111\/all.13397","volume":"73","author":"T Zuberbier","year":"2018","unstructured":"Zuberbier T, Aberer W, Asero R, Abdul Latiff AH, Baker D, Ballmer-Weber B, et al. The EAACI\/GA2LEN\/EDF\/WAO guideline for the definition, classification, diagnosis and management of urticaria. Allergy. 2018;73(7):1393\u2013414.","journal-title":"Allergy"},{"issue":"3","key":"946_CR7","doi-asserted-by":"publisher","first-page":"192","DOI":"10.1034\/j.1398-9995.2003.00054.x","volume":"58","author":"J Bousquet","year":"2003","unstructured":"Bousquet J, Van Cauwenberge P, Bachert C, Canonica GW, Demoly P, Durham SR, et al. Requirements for medications commonly used in the treatment of allergic rhinitis. Allergy. 2003;58(3):192\u20137. https:\/\/doi.org\/10.1034\/j.1398-9995.2003.00054.x.","journal-title":"Allergy"},{"issue":"1","key":"946_CR8","doi-asserted-by":"publisher","first-page":"131","DOI":"10.1185\/03007995.2011.648263","volume":"28","author":"J Bousquet","year":"2012","unstructured":"Bousquet J, Anstegui I, Walter Canonica G, Zuberbier T, Baena-Cagnani CE, Bachert C, et al. Establishing the place in therapy of bilastine in the treatment of allergic rhinitis according to ARIA: evidence review. Curr Med Res Opin. 2012;28(1):131\u20139. https:\/\/doi.org\/10.1185\/03007995.2011.648263.","journal-title":"Curr Med Res Opin"},{"issue":"9","key":"946_CR9","doi-asserted-by":"publisher","first-page":"1338","DOI":"10.1111\/j.1365-2222.2009.03257.x","volume":"39","author":"P Kuna","year":"2009","unstructured":"Kuna P, Bachert C, Nowacki Z, Van Cauwenberge P, Agache I, Fouquert L, et al. Efficacy and safety of bilastine 20 mg compared with cetirizine 10 mg and placebo for the symptomatic treatment of seasonal allergic rhinitis: a randomized, double-blind, parallel-group study. Clin Exp Allergy. 2009;39(9):1338\u201347.","journal-title":"Clin Exp Allergy"},{"issue":"1","key":"946_CR10","doi-asserted-by":"publisher","first-page":"121","DOI":"10.1185\/03007995.2011.640667","volume":"28","author":"J Sastre","year":"2012","unstructured":"Sastre J, Mullol J, Valero A, Valiente R. Efficacy and safety of bilastine 20 mg compared with cetirizine 10 mg and placebo in the treatment of perennial allergic rhinitis. Curr Med Res Opin. 2012;28(1):121\u201330.","journal-title":"Curr Med Res Opin"},{"key":"946_CR11","doi-asserted-by":"publisher","first-page":"12398","DOI":"10.3389\/jpps.2024.12398","volume":"27","author":"EAF Fernandes","year":"2024","unstructured":"Fernandes EAF, van Oudtshoorn J, Tam A, Gonz\u00e1lez LCA, Aurela EG, Potthast H, et al. The bioequivalence study design recommendations for immediate-release solid oral dosage forms in the international pharmaceutical regulators programme participating regulators and organisations: differences and commonalities. J Pharm Pharm Sci. 2024;27:12398.","journal-title":"J Pharm Pharm Sci"},{"key":"946_CR12","doi-asserted-by":"publisher","first-page":"375","DOI":"10.1007\/s40261-013-0076-y","volume":"33","author":"B Sadaba","year":"2013","unstructured":"Sadaba B, Gomez-Guiu A, Azanza JR, Ortega I, Valiente R. Oral availability of bilastine. Clin Drug Investig. 2013;33:375\u201381.","journal-title":"Clin Drug Investig"},{"issue":"8","key":"946_CR13","doi-asserted-by":"publisher","first-page":"543","DOI":"10.2165\/11317180-000000000-00000","volume":"48","author":"N Jauregizar","year":"2009","unstructured":"Jauregizar N, de la Fuente L, Lucero ML, Sologuren A, Leal N, Rodr\u00edguez M. Pharmacokinetic-pharmacodynamic modelling of the antihistaminic (H1) effect of bilastine. Clin Pharmacokinet. 2009;48(8):543\u201354.","journal-title":"Clin Pharmacokinet"},{"key":"946_CR14","unstructured":"Investigation of bioequivalence\u2014scientific guideline | European Medicines Agency. https:\/\/www.ema.europa.eu\/en\/investigationbioequivalence-scientific-guideline. Accessed 27 Oct 2024."},{"key":"946_CR15","unstructured":"FDA Guidance for Industry: bioavailability and bioequivalence studies for orally administered drug products\u2014general considerations\u2014ECA Academy. https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/fda-guidance-for-industry-bioavailabilityand-bioequivalence-studies-for-orally-administered-drug-products-general-consideration. Accessed 27 Oct 2024."},{"issue":"10","key":"946_CR16","doi-asserted-by":"publisher","first-page":"2369","DOI":"10.1111\/bcp.14055","volume":"85","author":"A Ring","year":"2019","unstructured":"Ring A, Lang B, Kazaroho C, Labes D, Schall R, Sch\u00fctz H. Sample size determination in bioequivalence studies using statistical assurance. Br J Clin Pharmacol. 2019;85(10):2369\u201377.","journal-title":"Br J Clin Pharmacol"},{"issue":"12","key":"946_CR17","doi-asserted-by":"publisher","first-page":"1011","DOI":"10.1007\/s40261-016-0447-2","volume":"36","author":"M Togawa","year":"2016","unstructured":"Togawa M, Yamaya H, Rodr\u00edguez M, Nagashima H. Pharmacokinetics, pharmacodynamics and population pharmacokinetic\/pharmacodynamic modelling of bilastine, a second-generation antihistamine, in Healthy Japanese Subjects. Clin Drug Investig. 2016;36(12):1011\u201321.","journal-title":"Clin Drug Investig"},{"issue":"Suppl. 1","key":"946_CR18","first-page":"148","volume":"101","author":"C Crean","year":"2007","unstructured":"Crean C, Roupe K, Sologuren A, Valiente R. The pharmacokinetics of bilastine after single and 14 days once daily administration. Basic Clin Pharmacol. 2007;101(Suppl. 1):148.","journal-title":"Basic Clin Pharmacol"},{"key":"946_CR19","doi-asserted-by":"publisher","first-page":"1338","DOI":"10.1111\/j.1365-2222.2009.03257.x","volume":"39","author":"P Kuna","year":"2009","unstructured":"Kuna P, Bachert C, Nowacki Z, Van Cauwenberge P, Agache I, Fouquert L, et al. Efficacy and safety of bilastine 20 mg compared with cetirizine 10 mg and placebo for the symptomatic treatment of seasonal allergic rhinitis: a randomized, double-blind, parallelgroup study. Clin Exp Allergy. 2009;39:1338\u201347.","journal-title":"Clin Exp Allergy"},{"key":"946_CR20","doi-asserted-by":"publisher","first-page":"158","DOI":"10.1111\/j.1398-9995.2008.01813.x","volume":"64","author":"C Bachert","year":"2009","unstructured":"Bachert C, Kuna P, Sanquer F, Ivan P, Dimitrov V, Gorina MM, et al. Comparison of the efficacy and safety of bilastine 20 mg vs desloratadine 5 mg in seasonal allergic rhinitis patients. Allergy. 2009;64:158\u201365.","journal-title":"Allergy"},{"key":"946_CR21","doi-asserted-by":"publisher","first-page":"391","DOI":"10.1007\/s00011-009-0117-4","volume":"59","author":"F Horak","year":"2010","unstructured":"Horak F, Zieglmayer P, Zieglmayer R, Lemell P. The effects of bilastine compared with cetirizine, fexofenadine, and placebo on allergen-induced nasal and ocular symptoms in patients exposed to aeroallergen in the Vienna Challenge Chamber. Inflamm Res. 2010;59:391\u20138.","journal-title":"Inflamm Res"},{"key":"946_CR22","doi-asserted-by":"publisher","first-page":"516","DOI":"10.1111\/j.1398-9995.2009.02217.x","volume":"65","author":"T Zuberbier","year":"2010","unstructured":"Zuberbier T, Oanta A, Bogacka E, Medina I, Wesel F, Uhl P, et al. Comparison of the efficacy and safety of bilastine 20 mg vs levocetirizine 5 mg for the treatment of chronic idiopathic urticaria: a multi-centre, double-blind, randomized, placebo-controlled study. Allergy. 2010;65:516\u201328.","journal-title":"Allergy"},{"issue":"3","key":"946_CR23","doi-asserted-by":"publisher","first-page":"405","DOI":"10.1007\/s40268-024-00480-8","volume":"24","author":"M Rom\u00e1n","year":"2024","unstructured":"Rom\u00e1n M, Ochoa D, Martin S, Luquero S, Gilaberte I, Arranz P, S\u00e1nchez C. Bioequivalence and safety of bilastine 20 mg orodispersible tablets and conventional tablets: a randomized, single-dose, two-period crossover study in healthy volunteers under fasting conditions. Drugs R D. 2024;24(3):405\u201314.","journal-title":"Drugs R D."}],"container-title":["European Journal of Drug Metabolism and Pharmacokinetics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s13318-025-00946-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s13318-025-00946-3\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s13318-025-00946-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,7,4]],"date-time":"2025-07-04T19:02:49Z","timestamp":1751655769000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s13318-025-00946-3"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,5,27]]},"references-count":23,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2025,7]]}},"alternative-id":["946"],"URL":"https:\/\/doi.org\/10.1007\/s13318-025-00946-3","relation":{},"ISSN":["0378-7966","2107-0180"],"issn-type":[{"value":"0378-7966","type":"print"},{"value":"2107-0180","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,5,27]]},"assertion":[{"value":"8 April 2025","order":1,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"27 May 2025","order":2,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"All the authors wish to acknowledge Synergen Bio Private Ltd for CRO support for the study.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Acknowledgements"}},{"value":"This research was conducted collaboratively by all authors. The study design, statistical analysis, and protocol writing were undertaken collectively by all the authors. All the authors oversaw the study analyses, managed literature searches, and contributed to the initial draft of the manuscript. All authors have read and agreed to the published version of the manuscript.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Author Contributions"}},{"value":"This study was funded by Glenmark Pharmaceuticals Ltd, India.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"The data presented in this study are available on request from the corresponding author.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Data Availability"}},{"value":"All authors are employees of Glenmark Pharmaceutical Ltd.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of Interest"}},{"value":"The study was conducted as per the ICMR Ethical Guidelines for Biomedical Research on Human Subjects, ICH-GCP Guidelines and in accordance with the Declaration of Helsinki and G.S.R. 227(E) New Drugs and Clinical Trials Rules, 2019 and Guidelines for Bioavailability and Bioequivalence Studies, Central Drugs Standard Control Organization, March 2005. Ethical approval IECSSHl 70123 was received on 17 th Jan 2023 from the Institutional Ethics Committee (Sai Sneh hospital and diagnostic centre, Pune, India).","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical Approval"}},{"value":"Informed consent was obtained from all the particpants enrolled in the study.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to Participate"}},{"value":"Informed consent was obtained from all the patients involved in the study.","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for Publication"}}]}}