Bioequivalence evaluation of two brands of meloxicam tablets (Promotion and Mobicox): pharmacokinetics in a healthy female Mexican population.
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-alpha), 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-alpha), 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.
Marcelín-Jiménez
G
G
Servicio de Investigación de Farmacología Clínica, Hospital General de México, Mexico City. gabmarcelin@hotmail.com
Hernández
José A
JA
Angeles
Alionka P
AP
Contreras
L
L
García
A
A
Hinojosa
M
M
Morales
M
M
Rivera
L
L
Martínez-Rossier
L
L
Fernández
A
A
D000284:Administration, Oral; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000097:blood / Q000493:pharmacokinetics*; D002851:Chromatography, High Pressure Liquid; D018592:Cross-Over Studies; D005260:Female; D006207:Half-Life; D006801:Humans; D000077239:Meloxicam; D008875:Middle Aged; D013607:Tablets; D013810:Therapeutic Equivalency; D013843:Thiazines / Q000097:blood / Q000493:pharmacokinetics*; D013844:Thiazoles / Q000097:blood / Q000493:pharmacokinetics*
D000894:Anti-Inflammatory Agents, Non-Steroidal; D013607:Tablets; D013843:Thiazines; D013844:Thiazoles; D000077239:Meloxicam