{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,18]],"date-time":"2026-01-18T03:01:58Z","timestamp":1768705318130,"version":"3.49.0"},"reference-count":18,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2024,11,13]],"date-time":"2024-11-13T00:00:00Z","timestamp":1731456000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2025,2]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Montelukast sodium is a leukotriene type 1 receptor antagonist that can be used for the prophylaxis and treatment of asthma. However, the pharmacokinetics of montelukast sodium tablets (10\u00a0mg) remain unclear in healthy Chinese subjects. Here, a single\u2010dose randomized, open\u2010label, 2\u2010sequence, and 2\u2010period crossover (7\u2010day washout period between treatments) study was performed to compare the pharmacokinetics and bioequivalence between the test products and the reference at a single dose of 10\u00a0mg among healthy Chinese subjects under fasting and fed conditions. Blood samples were collected at specified time points to analyze the plasma concentrations of montelukast by a validated liquid chromatography\u2010tandem mass spectrometry method. The results showed that the 90% confidence interval values of the geometric mean ratio of test\/reference for the maximum plasma drug concentration, area under the concentration\u2010time curve from time 0 to the end, and area under the concentration\u2010time curve from time 0 to infinity were within the range of 80%\u2010125%. Moreover, both the test and reference formulations were safe and well tolerated, with no occurrence of severe adverse events. These results demonstrate that both the test montelukast sodium tablets and the reference showed similar bioequivalence, safety, and tolerability among healthy Chinese subjects under fasting and fed conditions.<\/jats:p>","DOI":"10.1002\/cpdd.1485","type":"journal-article","created":{"date-parts":[[2024,11,14]],"date-time":"2024-11-14T05:18:21Z","timestamp":1731561501000},"page":"161-166","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Pharmacokinetics and Bioequivalence of Two Formulations of Montelukast Sodium Tablets in Healthy Chinese Volunteers Under Fasting and Fed Conditions"],"prefix":"10.1002","volume":"14","author":[{"given":"Xiali","family":"Rao","sequence":"first","affiliation":[{"name":"Office of Drug Clinical Trial Institution Xianning Central Hospital The First Affiliated Hospital of Hubei University of Science and Technology  Xianning P.R. China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xinghong","family":"Wu","sequence":"additional","affiliation":[{"name":"Department of Oncology Xianning Central Hospital The First Affiliated Hospital of Hubei University of Science and Technology  Xianning P.R. China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jiawei","family":"Hu","sequence":"additional","affiliation":[{"name":"Office of Drug Clinical Trial Institution Xianning Central Hospital The First Affiliated Hospital of Hubei University of Science and Technology  Xianning P.R. China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zhaoming","family":"Huang","sequence":"additional","affiliation":[{"name":"Department of Medical Cosmetology Xianning Central Hospital The First Affiliated Hospital of Hubei University of Science And Technology  Xianning P.R. China"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2024,11,13]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1186\/1939-4551-7-12"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaip.2017.05.001"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(19)31147-X"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1067\/mai.2003.22"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1023\/A:1016056912698"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1124\/dmd.110.037689"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00228-012-1239-0"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.2147\/DDDT.S298355"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.21037\/atm-22-6485"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1067\/mai.2000.109424"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1055\/s-0033-1347235"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13601-015-0081-8"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.5414\/CPP48628"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1124\/pr.115.011411"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1124\/dmd.115.065763"},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.3109\/10717544.2016.1170247"},{"key":"e_1_2_9_18_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40265-017-0832-z"},{"key":"e_1_2_9_19_1","doi-asserted-by":"publisher","DOI":"10.2165\/00003495-200059001-00006"}],"container-title":["Clinical Pharmacology in Drug Development"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.1485","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,2,3]],"date-time":"2025-02-03T10:25:43Z","timestamp":1738578343000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1002\/cpdd.1485"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,11,13]]},"references-count":18,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2025,2]]}},"alternative-id":["10.1002\/cpdd.1485"],"URL":"https:\/\/doi.org\/10.1002\/cpdd.1485","archive":["Portico"],"relation":{},"ISSN":["2160-763X","2160-7648"],"issn-type":[{"value":"2160-763X","type":"print"},{"value":"2160-7648","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,11,13]]},"assertion":[{"value":"2024-09-21","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-10-23","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-11-13","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}