RefDoc
Haut

Faire une nouvelle recherche
Make a new search
Lancer la recherche


Titre du document / Document title

Bioequivalence of 250 mg lysine clonixinate tablets after a single oral dose in a healthy female Mexican population under fasting conditions

Auteur(s) / Author(s)

MARCELIN-JIMENEZ G. ; ANGELES A. C. P. ; GARCIA A. ; MORALES M. ; RIVERA L. ; MARTIN-DEL-CAMPO A. ;

Résumé / Abstract

Objective: To evaluate the bio-equivalence between two 250 mg-tablets of lysine clonixinate, Dorixina Forte® (Siegfried Rhein, México) as reference product, and Prestodol® (Farmaceúticos Rayere, S.A., México) as test formulation. Methods: 26 healthy adult female Mexican volunteers received a single oral dose of 250-mg lysine clonixinate under fasting conditions. The drug was administered following a randomized, two-period, two-sequence, cross-over design. Twelve serial blood samples were collected up to 8 h after dosing, and clonixin (CLX) was measured by ultra-performance liquid chromatography (UPLC) coupled with tandem mass spectrometry. Decimal logarithm values of Cmax and area under the curve (AUC) were used to construct a classic confidence interval at 90% (90% CI). Bioequivalence was established if 90% CI of mean ratios (test/reference) fall within the 0.8 - 1.25 range. Results: Volunteers formed a homogeneous population in terms of age (27.2 ± 6.3 years), weight (55.9 ± 6.5 kg), height (1.6 ± 0.04 m), and body mass index (BMI) (22.91 ± 2.03 kg/m2). Reference formulation exhibited the following pharmacokinetics: Cmax (32.39 ± 8.32 μg/ml); tmax (0.64 ± 0.2 h); AUC0-8h (48.92 ± 16.51 μg.h/ml); t1/2 (1.3 ± 0.24 h); CLapp (5.64 ± 1.99 l/h), and Vdapp (10.22 ± 2.9 l). Concerning bioequivalence, 90% CI were: Cmax (82.32 - 98.79), AUC0-t (94.59-106.29), and AUC0-inf (94.61 - 106.42), with a statistical power of > 0.90 at every tested interval. Conclusions: This single-dose study found that both 250-mg immediate-release tablets of lysine clonixinate met the Mexican regulatory criteria for bioequivalence in these volunteers.

Revue / Journal Title

International journal of clinical pharmacology and therapeutics    ISSN  0946-1965 

Source / Source

2010, vol. 48, no5, pp. 349-354 [6 page(s) (article)]

Langue / Language

Anglais

Editeur / Publisher

Dustri, München, ALLEMAGNE  (1994) (Revue)

Mots-clés d'auteur / Author Keywords

lysine clonixinate

;

Chemical Abstracts Society (CAS) registry no. 55837-30-4

;

bio-equivalence and pharmacokinetics

;

ultra-performance liquid chromatography (UPLC)

;

tandem mass spectrometry

;

Localisation / Location

INIST-CNRS, Cote INIST : 15902, 35400018105685.0070

Nº notice refdoc (ud4) : 22682043



Faire une nouvelle recherche
Make a new search
Lancer la recherche
Bas