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Bioequivalence study of a novel orodispersible tablet of meloxicam in a porous matrix after single-dose administration in healthy volunteers

Milko Radicioni, Sandra Connolly, Federico Stroppolo, Gabriele Granata, Luca Loprete and Chiara Leuratti

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Volume 51 p. 234 - 243

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 51 – No. 3/2013 (234-243)

Bioequivalence study of a novel orodispersible tablet of meloxicam in a porous matrix after single-dose administration in healthy volunteers

Milko Radicioni¹, Sandra Connolly², Federico Stroppolo³, Gabriele Granata³, Luca Loprete¹ and Chiara Leuratti⁴

¹CROSS Research S.A., Arzo, Switzerland, ²MDS Pharma Services (now Celerion), Early Clinical Research, Neptune, NJ, USA, ³Alpex Pharma S.A., Mezzovico, and ⁴CROSS S.A., Arzo, Switzerland
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 C_max, AUC_0–t and AUC_0–∞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 C_max, AUC_0–t and AUC_0–∞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.Correspondence to:
Dr. Chiara Leuratti
Cross S.A.
via L. Lavizzari 18
6850 Mendrisio, Switzerland
Email: [email protected]

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