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 a...

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Bibliographic Details
Published in:Biopharmaceutics & drug disposition 2005-07, Vol.26 (5), p.167-171
Main Authors: Marcelín-Jiménez, G., Hernández, José A., Ángeles, Alionka P., Contreras, L., García, A., Hinojosa, M., Morales, M., Rivera, L., Martínez-Rossier, L., Fernández, A.
Format: Article
Language:English
Subjects:
Administration, Oral
Adult
Anti-Inflammatory Agents, Non-Steroidal - blood
Anti-Inflammatory Agents, Non-Steroidal - pharmacokinetics
bioequivalence
Biological and medical sciences
Chromatography, High Pressure Liquid
Cross-Over Studies
Female
Half-Life
high-performance liquid chromatography (HPLC)
Humans
Medical sciences
meloxicam
Middle Aged
pharmacokinetics
Pharmacology. Drug treatments
Tablets
Therapeutic Equivalency
Thiazines - blood
Thiazines - pharmacokinetics
Thiazoles - blood
Thiazoles - pharmacokinetics
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Summary: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 AUC0–t, AUC0–α, Cmax, Tmax, ke, MRT and t1/2 were determined from plasma concentrations of both formulations, resulting in a Cmax 120% larger than and a Tmax 65% faster than those reported in other populations. AUC0–t, AUC0–α, and Cmax 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
ISSN:0142-2782
1099-081X
DOI:10.1002/bdd.446