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- W2364511128 abstract "OBJECTIVE an accurate and sensitive LC-MS method was established to determine the concentration of erythromycylamine in human plasma and studied relative bioavailability of Dirithromycin Enteric-coated micro-pill capsule in healthy Chinese volunteers.METHODS A single oral dose of 500 mg test or reference preparations of Dirithromycin was given to 20 healthy volunteers in a randomized crossover study. The plasma concentrations of erythromycylamine were determined by LC-MS assay. The pharmacokinetics and bioavailability were studied.RESULTS The detection limit of erythromycylamine in plasma was 4.5 ng·L-1and a good linearity was obtained over the range of 4.5-720 μg·L-1(r=0.999 8, n=5). The relative standard deviation of within-day and between-day was less 10%.The pharmacokinetic parameters for test and reference drugs after a single oral dose were as follows: AUC0→96(3025.6±690.9)and (2 862.8±672.1) μg·h·L-1; AUC0→∞(3 679.0±888.1)and (3 500.9±813.2) μg·h·L-1; Cmax(390.4±81.2)and (396.0±63.2) μg·L-1; tmax(3.3±0.4)and (3.35±0.29) h, the relative bioavailability of tested preparation was(107.6±20.2)%.CONCLUSION Statistic analysis shows no significant differences between the two preparations, and bioequivalence is observed. The established LC-MS method is accuracy and sensible for erythromycylamine determination and assaying relative bioavailability of Dirithromycin Enteric-coated micro-pill capsule." @default.
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- W2364511128 date "2007-01-01" @default.
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- W2364511128 title "Relative bioavailability of dirithromycin enteric-coated micro-pill capsule in healthy volunteers" @default.
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