Several clinical trials have substantiated the efficacy of the co-administration of statins like atorvastatin (ATO) and fibrates. Without information currently available about the interaction between the two drugs, a pharmacokinetic study was conducted to investigate the effect when both drugs were co-administered. The purpose of this study was to investigate the pharmacokinetic profile of tablets containing ATO 20 mg, or the combination of ATO 20 mg with fenofibrate (FNO) 160 mg administered to healthy Mexican volunteers. This was a randomized, two-period, two-sequence, crossover study; 36 eligible subjects aged between 20–50 years were included. Blood samples were collected up to 96 h after dosing, and pharmacokinetic parameters were obtained by non-compartmental analysis. Adverse events were evaluated based on subject interviews and physical examinations. Area under the concentration-time curve (AUC) and maximum plasma drug concentration (Cmax) were measured for ATO as the reference and ATO and FNO as the test product for bioequivalence design. The estimation computed (90% confidence intervals) for ATO and FNO combination versus ATO for Cmax, AUC0-t and AUC0-∞, were 102,09, 125,95, and 120,97%, respectively. These results suggest that ATO and FNO have no relevant clinical-pharmacokinetic drug interaction.
Introducción: Staphylococcus aureus es uno de los patógenos con mayor prevalencia en el mundo, asociado a una alta tasa de mortalidad y un rápido desarrollo de resistencia a los antimicrobianos. A pesar de su patogenicidad, su seguimiento epidemiológico en México es escaso. Objetivo: Analizar la epidemiología molecular local y determinar el origen clonal de cepas resistentes a meticilina (RM) aisladas de pacientes internados en el Hospital Central "Dr. Ignacio Morones Prieto". Métodos: Se llevó a cabo un estudio prospectivo de corte transversal, de julio a diciembre de 2016. La caracterización de las cepas se realizó mediante genotipificación Spa, la determinación por RPC punto final de la frecuencia de genes de virulencia específicos y su antibiograma. Resultados: A partir de estos datos, se obtuvo que la prevalencia de S. aureus RM fue de 25,7%, destacando la presencia del tipo Spa t895 en 76% de las cepas resistentes y un patrón similar de susceptibilidad a antimicrobianos. Conclusión: Los resultados de este estudio indican que la prevalencia regional de SARM no se ha modificado en los últimos 10 años y proporcionan información valiosa del origen clonal y los factores de virulencia de las cepas de S. aureus aisladas en la región.
Background:
Synthetic glucocorticoids like Betamethasone (BE) are used in the treatment of
inflammatory diseases due to its effective and potent effect. BE is available in three different esters:
dipropionate (BD), sodium phosphate (BP), and acetate (BA). BD/BP combined in suspension has antiinflammatory,
anti-allergic, and anti-rheumatic effects. The aim of this study was to describe the
bioavailability of a single-dose of the injectable formulation of BP/BD in healthy Mexican subjects.
Methods:
This was a randomized, open-label, longitudinal, not therapeutic, single-dose trial of an intramuscular
administration of BD/BP (5 mg/2 mg), in healthy Mexican subjects under fasting condition.
Twenty-six healthy Mexicans volunteers of both genders who were between the ages of 18 and 45 were
enrolled in the study.
Results:
From non-compartmental estimation of data, it was observed that the BE highest mean concentration
was 15.70 ± 3.93 ng/mL reaching it in 2.83 ± 1.35 h. The values of elimination half-life were
10.89 ± 2.02 h. No clinically significant adverse effects were presented during the study.
Conclusion:
The reported PK parameters for BE suggest that the BD/BP suspension has a similar release
velocity in Mexican healthy subjects compared with previous studies.
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