Advanced search
Publication Cover
Drug Design, Development and Therapy Volume 15, 2021 - Issue
Submit an article Journal homepage
283
Views
2
CrossRef citations to date
0
Altmetric
Original Research

Pharmacokinetics and Bioequivalence Evaluation of Two Montelukast Sodium Chewable Tablets in Healthy Chinese Volunteers Under Fasted and Fed Conditions

Weihong Li1 GCP Office of Cangzhou Central Hospital, Cangzhou, Hebei, 061000, People’s Republic of ChinaCorrespondence[email protected]
,
Yanrong Wang1 GCP Office of Cangzhou Central Hospital, Cangzhou, Hebei, 061000, People’s Republic of China
,
Yingzi Pei2 Research Center of Beijing Fuyuan Pharmaceutical Co., Ltd. (Formerly Beijing Wansheng Pharmaceutical Co., Ltd.), Beijing, 101113, People’s Republic of China
&
Yue Xia2 Research Center of Beijing Fuyuan Pharmaceutical Co., Ltd. (Formerly Beijing Wansheng Pharmaceutical Co., Ltd.), Beijing, 101113, People’s Republic of China
Pages 1091-1099 | Published online: 09 Mar 2021

References

  • EllisKL, FanLT, LeungAKC. Clinical effectiveness and safety of montelukast in asthma. What are the conclusions from clinical trials and meta-analyses? Drug Des Devel Ther. 2014;2014:839–850. doi:10.2147/DDDT.S39100
  • ZubairiABS, SalahuddinN, KhawajaA, et al. A randomized, double-blind, placebo-controlled trial of oral montelukast in acute asthma exacerbation. BMC Pulm Med. 2013;13(1):1–7. doi:10.1186/1471-2466-13-2023305075
  • YangDZ, LiangJ, ZhangF, YaoHB, ShuY. Clinical effect of montelukast sodium combined with inhaled corticosteroids in the treatment of osas children. Medicine. 2017;96(19):e6628. doi:10.1097/MD.000000000000662828489737
  • JoosS, MikschA, SzecsenyiJ, et al. Montelukast as add-on therapy to inhaled corticosteroids in the treatment of mild to moderate asthma: a systematic review. Thorax. 2008;63(5):453–462. doi:10.1136/thx.2007.08159618443162
  • KeithPK, KochC, DjandjiM, et al. Montelukast as add-on therapy with inhaled corticosteroids alone or inhaled corticosteroids and long-acting beta-2-agonists in the management of patients diagnosed with asthma and concurrent allergic rhinitis (the RADAR trial). Can Respir J. 2016;16(Suppl A):17A. doi:10.1155/2009/145071
  • MontellaS, MaglioneM, StefanoSD, et al. Update on leukotriene receptor antagonists in preschool children wheezing disorders. Ital J Pediatr. 2012;38(1):29. doi:10.1186/1824-7288-38-2922734451
  • NaserZA, MuradA, DavidW, et al. Investigation of the bioequivalence of montelukast chewable tablets after a single oral administration using a validated LC-MS/MS method. Drug Des Devel Ther. 2015;9:5315. doi:10.2147/DDDT.S87938
  • KimS, KimKJW JR, KimJ-R. Comparison of the pharmacokinetics and tolerability of montelukast/levocetirizine administered as a fixed-dose combination and as separate tablets. Int J Clin Pharmacol Ther. 2018;56(9):443–450. doi:10.5414/CP20326530021691
  • MoonSJ, YuKS, JungJ, KimY, KimMG. Comparative pharmacokinetics of a montelukast/levocetirizine fixed-dose combination chewable tablet versus individual administration of montelukast and levocetirizine after a single oral administration in healthy Korean male subjects. Int J Clin Pharmacol Ther. 2020;58(6):354–362. doi:10.5414/CP20370932271144
  • DennisonJ, PuriA, WarringtonS, et al. Amenamevir: studies of potential CYP2C8‐ and CYP2B6‐mediated pharmacokinetic interactions with montelukast and bupropion in healthy volunteers. Clin Pharmacol Drug Dev. 2018;7(8):860–870. doi:10.1002/cpdd.57829870591
  • CardosoJDO, OliveiraRV, LuJBL, et al. In vitro metabolism of montelukast by cytochrome P450s (CYPs) and UDP-glucuronosyltransferases (UGTs). Drug Metab Dispos. 2015;43(12):1905–1916. doi:10.1124/dmd.115.06576326374173
  • KaronenT, NeuvonenPJ, BackmanJT. CYP2C8 but not CYP3A4 is important in the pharmacokinetics of montelukast. Br J Clin Pharmacol. 2012;73(2):257–267. doi:10.1111/j.1365-2125.2011.04086.x21838784
  • HaarmanMG, Van HunselF, De VriesTW. Adverse drug reactions of montelukast in children and adults. Pharmacol Res Perspect. 2017;5(5):e00341. doi:10.1002/prp2.341
  • ArnoldDH, BowmanN, ReissTF, HartertTV, SegerDL. Adverse events are rare after single-dose montelukast exposures in children. Clin Toxicol (Phila). 2018;56(1):25–29. doi:10.1080/15563650.2017.133712328639856
  • KimHT, SongYK, LeeSD, ParkY, KimCK. Relative bioavailability of two 5-mg montelukast sodium chewable tablets: a single dose, randomized, open-label, 2-period crossover comparison in healthy Korean adult male volunteers. Arzneimittelforschung. 2012;62(3):123–127. doi:10.1055/s-0031-129800422407900
  • World Medical Association. Declaration of Helsinki. Available from: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/. Accessed 31, 2019.
  • The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Guideline for good clinical practice. Available from: https://www.ich.org/products/guidelines/efficacy/efficacy-single/article/integrated-addendum.good-clinical-practice.html. Accessed 31, 2019.
  • National Medical Products Administration. Guideline for good clinical practice. Available from: http://www.nmpa.gov.cn/WS04/CL2101/329583.html. Accessed 618, 2020.
  • National Medical Products Administration. Center for Drug Evaluation. Guideline for bioavailability and bioequivalence studies of generic drug products. Available from: http://www.nmpa.gov.cn/WS04/CL2093/331454.html. Accessed 618, 2020.

Related research

People also read lists articles that other readers of this article have read.

Recommended articles lists articles that we recommend and is powered by our AI driven recommendation engine.

Cited by lists all citing articles based on Crossref citations.
Articles with the Crossref icon will open in a new tab.