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Pharmacokinetics and Bioequivalence Study of a New Branded Generic Moxifloxacin Tablet Among Healthy Volunteers

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dc.contributor.authorAtiqah Amran,en_US
dc.contributor.authorChing Yee Tan,en_US
dc.contributor.authorKa-Liong Tan,en_US
dc.contributor.authorRanald Malcom Ho,en_US
dc.contributor.authorAnil Kumar Anand,en_US
dc.contributor.authorChuei Wuei Leongen_US
dc.date.accessioned2024-05-28T08:43:30Z
dc.date.available2024-05-28T08:43:30Z
dc.date.issued2021
dc.date.submitted2022-1-27
dc.descriptionClinical Pharmacology in Drug DevelopmentVolume 10, Issue 12, Pages 1514 - 1518December 2021en_US
dc.description.abstractA newly developed branded generic of a moxifloxacin (MOX) 400-mg tablet formulation was manufactured prior to this study. A bioequivalence (BE) study was done to assess the pharmacokinetics of the formulation using a randomized, open-label, 2-period crossover, 2-sequence, and single-dose experiment. Thirty healthy male volunteers were recruited. The test formulation, Flonoxin 400 mg, was compared with the reference formulation, Avelox 400 mg. The pharmacokinetic parameters of MOX were calculated based on the plasma drug concentration-time profile. Noncompartmental analysis was performed to determine its safety and tolerability. The 90% confidence intervals (CIs) were 88.5%-104.6%, 96.1%-101.1%, and 96.8%-100.7% for Cmax, AUC0-t, and AUC0-inf, respectively. All CIs were within the 80.0%-125.0% boundary, thus fulfilling the acceptable BE criteria according to the ASEAN guidelines.en_US
dc.identifier.citationAmran, A., Tan, C.Y., Tan, K.-L., Ho, R.M., Anand, A.K. and Leong, C.W. (2021), Pharmacokinetics and Bioequivalence Study of a New Branded Generic Moxifloxacin Tablet Among Healthy Volunteers. Clinical Pharmacology in Drug Development, 10: 1514-1518. https://doi.org/10.1002/cpdd.964en_US
dc.identifier.doi10.1002/cpdd.964
dc.identifier.doihttps://accp1.onlinelibrary.wiley.com/doi/10.1002/cpdd.964
dc.identifier.epage1518
dc.identifier.issn2160-7648
dc.identifier.issue12
dc.identifier.other2224-12
dc.identifier.spage1514
dc.identifier.urihttps://www.scopus.com/record/display.uri?eid=2-s2.0-85107598778&origin=resultslist&sort=plf-f&src=s&st1=Pharmacokinetics+and+Bioequivalence+Study+of+a+New+Branded+Generic+Moxifloxacin+Tablet+Among+Healthy+Volunteers&sid=31be55ee0bda8589898f4899befb35db&sot=b&sdt=b&sl=126&s=TITLE-ABS-KEY%28Pharmacokinetics+and+Bioequivalence+Study+of+a+New+Branded+Generic+Moxifloxacin+Tablet+Among+Healthy+Volunteers%29&relpos=0&citeCnt=1&searchTerm=
dc.identifier.urihttps://oarep.usim.edu.my/handle/123456789/9352
dc.identifier.volume10
dc.language.isoenen_US
dc.publisherWileyen_US
dc.relation.ispartofClin Pharmacol Drug Deven_US
dc.subjectbioequivalence study; moxifloxacin; new branded genericsen_US
dc.titlePharmacokinetics and Bioequivalence Study of a New Branded Generic Moxifloxacin Tablet Among Healthy Volunteersen_US
dc.typeArticleen_US
dspace.entity.typePublication

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