Premium
Bioequivalence evaluation of two brands of meloxicam tablets (promotion® and mobicox®): pharmacokinetics in a healthy female Mexican population
Author(s) -
MarcelínJiménez G.,
Hernández José A.,
Ángeles Alionka P.,
Contreras L.,
García A.,
Hinojosa M.,
Morales M.,
Rivera L.,
MartínezRossier L.,
Fernández A.
Publication year - 2005
Publication title -
biopharmaceutics and drug disposition
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.419
H-Index - 58
eISSN - 1099-081X
pISSN - 0142-2782
DOI - 10.1002/bdd.446
Subject(s) - bioequivalence , pharmacokinetics , bioavailability , crossover study , meloxicam , confidence interval , medicine , pharmacology , population , high performance liquid chromatography , plasma concentration , chromatography , chemistry , alternative medicine , environmental health , pathology , placebo
We conducted a randomized, crossover study in 23 healthy young female volunteers to compare the bioavailability of two brands of meloxicam (7.5 mg) tablets and to obtain pharmacokinetic parameters of this molecule in Mexican population not reported previously. Two tablets (15 mg) were administered as a single dose on 2 treatment days separated by a 1‐week washout period. After dosing, serial blood samples were collected for a period of 72 h. Plasma harvested was analyzed for meloxicam by a modified and validated high‐performance liquid chromatography (HPLC) method previously reported. Pharmacokinetic parameters AUC 0– t , AUC 0– α , C max , T max , k e , MRT and t 1/2 were determined from plasma concentrations of both formulations, resulting in a C max 120% larger than and a T max 65% faster than those reported in other populations. AUC 0– t , AUC 0– α , and C max were statistically tested for bioequivalence after log transformation data in a non‐balanced design, and no significant differences were found either in 90% classical confidence interval (90% CI) or in Schuirmann test ( p <0.05); thus, we concluded that bioequivalence existed between both formulations. Copyright © 2005 John Wiley & Sons, Ltd.