Détail de la notice
Titre du Document
Bioequivalence of 250 mg lysine clonixinate tablets after a single oral dose in a healthy female Mexican population under fasting conditions
Auteur(s)
MARCELIN-JIMENEZ G. ; ANGELES A. C. P. ; GARCIA A. ; ...
Résumé
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
Editeur
Dustri
Identifiant
PMID : 20420792 ISSN : 0946-1965
Source
International journal of clinical pharmacology and therapeutics A. 2010, vol. 48, n° 5, pp. 349-354 [6 pages]
Langue
Anglais
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