PMID: 18184536Jan 11, 2008Paper

Comparative bioavailability study of two phenoxymethylpenicillin potassium tablet formulations in healthy volunteers

International Journal of Clinical Pharmacology and Therapeutics
R A MorenoN C Borges

Abstract

The aim of this study was to evaluate the performance of 2 phenoxymethylpenicillin 500,000 UI tablet formulations in healthy human volunteers. The study was conducted using an open, randomized crossover design with a 7-day washout interval. A single dose of each formulation was administered to 26 healthy volunteers as assessed by clinical and laboratory test evaluations. The plasma samples were obtained over an 8-h interval and phenoxymethylpenicillin concentrations were quantified by a suitable and validated HPLC-UV method with detection at 220 nm. Systolic and diastolic blood pressure and pulse rate measurement were taken pre dose and at intervals up to 8 h. Tolerance of both products was adequate. The mean of Meracilina/Pen-Ve-Oral 500,000 UI% geometric mean was 99.89% for AUC0-t, 100.86% for AUC0-infinity and 101.11% for Cmax. The 90% confidence intervals were 94.62 - 105.46%, 95.22 - 106.83% and 98.61 - 103.87%, respectively. The mean recovery of phenoxymethylpenicillin was 94.8%, while the retention time observed for phenoxymethylpenicillin and phenytoin (internal standard) was 4 and 10 min, respectively. The limit of quantification was 0.10 mg/l. Since the 90% CI for AUC0-t, AUC0-infinity and Cmax ratios were all within ...Continue Reading

Citations

Mar 15, 2014·BMC Infectious Diseases·Awad Al-OmariVicente F Corrales-Medina
Dec 24, 2009·Tidsskrift for den Norske lægeforening : tidsskrift for praktisk medicin, ny række·Andreas Austgulen WestinOlav Spigset

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