Study on relative bioavailability of two kinds of roxithromycin tablets in healthy volunteers
HE Hai-xia
Abstract
HE Hai-xia
Abstract
Objective To evaluate the bioavailability of two kinds of roxithromycin tablets in healthy volunteers.Methods A randomized crossover design was performed in 20 healthy volunteers,150mg of roxithromycin tablets and preparation tablets were given respectively.The serum concentration of roxithromycin tablets were determined by microbial plate assay.The pharmacokinetics were calculated by program of 3p97.Results The concentration-time curves of tablets both fitted to two-compartment open models.The main pharmacokinetic parameters were as follows:t_(1/2)β were(7.96±3.46)h and(10.46±5.10)h,Cmax were(7.67±2.18)μg/ml and(7.15±2.74)μg/ml,Tmax were(1.82±1.00)h and(2.10±1.22)h;AUC_((0~T)) were(66.36±45.35)μg·h~(-1)·ml~(-1) and(67.65±43.60)μg·h~(-1)·ml~(-1),respectively.Conclusion Both roxithromycin tablets were bioequivalent.The relative bioavailability of test roxithromycin tablets was(98.09±11.90)%.
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Objective To evaluate the bioavailability of two kinds of roxithromycin tablets in healthy volunteers.Methods A randomized crossover design was performed in 20 healthy volunteers,150mg of roxithromycin tablets and preparation tablets were given respectively.The serum concentration of roxithromycin tablets were determined by microbial plate assay.The pharmacokinetics were calculated by program of 3p97.Results The concentration-time curves of tablets both fitted to two-compartment open models.The main pharmacokinetic parameters were as follows:t_(1/2)β were(7.96±3.46)h and(10.46±5.10)h,Cmax were(7.67±2.18)μg/ml and(7.15±2.74)μg/ml,Tmax were(1.82±1.00)h and(2.10±1.22)h;AUC_((0~T)) were(66.36±45.35)μg·h~(-1)·ml~(-1) and(67.65±43.60)μg·h~(-1)·ml~(-1),respectively.Conclusion Both roxithromycin tablets were bioequivalent.The relative bioavailability of test roxithromycin tablets was(98.09±11.90)%.
Key concepts: Roxithromycin, Bioequivalence, Bioavailability, Pharmacokinetics, Cmax, Crossover study, Chemistry, Chromatography