Document Detail


Bioequivalence study of a novel orodispersible tablet of meloxicam in a porous matrix after single-dose administration in healthy volunteers.
MedLine Citation:
PMID:  23380429     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
Background: Meloxicam is a non-steroidal anti-inflammatory drug, indicated for osteoarthritis exacerbations, rheumatoid arthritis and ankylosing spondylitis symptomatic treatment. Objective: To compare the bioavailability of a 15 mg meloxicam orodispersible tablet (ODT) and a reference 15 mg tablet in healthy volunteers. Methods: Two randomized, crossover, bioequivalence studies were conducted. In both studies, 28 volunteers were randomly assigned to receive test ODT and reference tablet formulations in single dose under fasting conditions in two study periods, with a 7-day (Study I) or 14-day (Study II) wash-out between administrations. Blood samples were collected at pre-specified times. Pharmacokinetic parameters were obtained by noncompartmental analysis. Bioequivalence was assumed if the 90% confidence interval of the test/reference ratio of the least-squares means for Cmax, AUC0-t and AUC0-∞were within the 80.00 -125.00% range, according to the current guidelines. Results: All 28 subjects in Study I and 26 subjects in study II completed the study and were included in the analysis. The 90% confidence intervals of the geometric means ratios for the logtransformed Cmax, AUC0-t nd AUC0-∞were 87 -96%, 88 -96% and 87 -96% in Study I, and 99 -105%, 98 -104% and 108 -120% in Study II. Test product was characterized by a slightly earlier tmax than the reference, i.e., 4.9 ±1.1 vs. 5.8 ±2.6 hours in Study I (p = 1.000) and 3.8 ±2.0 vs. 4.8 ±1.6 hours in Study II (p = 0.0054). The two drugs were well tolerated. Conclusions: Test and reference formulations met the regulatory criteria for bioequivalence in the fasting healthy volunteers enrolled.
Authors:
Milko Radicioni; Sandra Connolly; Federico Stroppolo; Gabriele Granata; Luca Loprete; Chiara Leuratti
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2013-2-5
Journal Detail:
Title:  International journal of clinical pharmacology and therapeutics     Volume:  -     ISSN:  0946-1965     ISO Abbreviation:  Int J Clin Pharmacol Ther     Publication Date:  2013 Feb 
Date Detail:
Created Date:  2013-2-5     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9423309     Medline TA:  Int J Clin Pharmacol Ther     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
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