ObjectiveThe aim of this clinical trial was to establish the bioequivalence of two tablets containing acetaminophen 650 mg (reference) and acetaminophen 650 mg plus caffeine 65 mg (test), administered orally, in fasting conditions in healthy Mexican volunteers.MethodsBlood samples were taken from 21 male and five female individuals, during a 24-h period, to characterize the pharmacokinetic profile of acetaminophen. Plasma samples were quantified by ultra-performance liquid chromatography, tandem mass spectrometry. Pharmacokinetic metrics (maximum plasma concentration, area under the curve from time zero to the last sampling time, and area under the curve from time zero to infinity) were used to determine the 90 % confidence interval of the test/reference coefficient.ResultsThe geometric mean values for maximum plasma concentration obtained for the reference and test products were 9.46 ± 34.21 and 9.72 ± 32.38 µg/mL, respectively, whereas for the area under the curve from time zero to the last sampling time the values obtained were 34.93 ± 32.58 and 35.89 ± 31.03 µg h/mL for the reference and test formulations, respectively. The 90 % confidence intervals were within the acceptance range (80–125 %).ConclusionsThe test product was bioequivalent to the reference product. A faster absorption was seen in the test formulation in the Mexican population.
Objetivo: identificar la relación de Acantosis nigricans (an) con obesidad y Resistencia a la Insulina (ri) en niños y adolescentes de 10 a 16 años. Material y métodos: estudio descriptivo, transversal. Previa firma de consentimiento informado se incluyó una muestra no probabilística por conveniencia de 146 niños y adolescentes de entre 10 a 16 años de mayo 2008 a junio 2009; se categorizaron en dos grupos: 69 con an y 77 sin an. Se evaluaron las siguientes variables: glucosa e insulina en ayuno y postprandial, triglicéridos, colesterol, lipoproteínas de alta densidad, presión arterial, peso, talla, Índice de Masa Corporal (imc) y composición corporal; posteriormente se calculó el índice homa (modelo de evaluación de la homeostasis). Se establecieron puntos de corte de acuerdo con atp iii (Adult Treatment Panel), las diferencias entre grupos se analizaron con t de Student. Resultados: la edad de la muestra estudiada no presentó diferencias significativas entre adolescentes con an 12.9±1.9 y sin an 13.05±2.1. Se encontraron diferencias significativas en las siguientes variables: peso: an 66.7±14.1, sin an 60.53±15.7 p=.01; imc: an 27.5±3.9, sin an 24.8±7.3 p=.008; homa: an 3.9±2.5, sin an 2.8±3.2 p=.034; colesterol: an 173.5±32.8, sin an 160.9±37.6 p=.03; triglicéridos: an 150.9±63.3, sin an 119.5±66.5 p=.004; lipoproteínas de alta densidad (hdl): an 35.1±7.3, sin an 41.0±8.9 p=.00; Presión Arterial Sistólica (pas): an 115.7±11.6, sin an 111.74±10.4 p=.02; Presión Arterial Diastólica (pad): an 74.0±9.5, sin an 69.19±8.5 p=.001. Conclusiones: 100% de los niños y adolescentes con an presentaron alguna alteración ya sea clínica o bioquímica, en estos adolescentes es imperativo la evaluación clínica completa y su atención médica inmediata.
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