Study on Relative Bioavailability of Cefaclor Capsules in Human Body
Zhao Xu-yuan
Abstract
Zhao Xu-yuan
Abstract
OBJECTIVE:To evaluate the relative bioavailability of2kinds of preparations of cefaclor capsules.METHˉODS:The subjects'blood concentrations were determined by HPLC at different time after administered randomly crossover with single oral dose of cefaclor testing preparation or reference preparation.The actual values of C max and T max were adopted;AUC was calculated by trapezoid planimetry;the bioequiavailability of the2preparations were evaluated by two-sides and one-side t-test.RESULTS:The AUC 0~4 of the testing preparation and reference preparation were respectively(13.44±3.06)(μg·h)/ml and(14.19±3.28)(μg·h)/ml;their respective AUC 0~∞ were(13.80±3.08)(μg·h)/ml and(14.62±3.33)(μg·h)/ml;their respective C max were(11.65±2.39)μg/ml and(12.37±2.41)μg/ml;their respective t max were(0.57±0.24)h and(0.66±0.19)h.The relative bioavailability of testing preparation was(95.62±13.51)%.CONˉCLUSION:The2preparations are bioequivalent.
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OBJECTIVE:To evaluate the relative bioavailability of2kinds of preparations of cefaclor capsules.METHˉODS:The subjects'blood concentrations were determined by HPLC at different time after administered randomly crossover with single oral dose of cefaclor testing preparation or reference preparation.The actual values of C max and T max were adopted;AUC was calculated by trapezoid planimetry;the bioequiavailability of the2preparations were evaluated by two-sides and one-side t-test.RESULTS:The AUC 0~4 of the testing preparation and reference preparation were respectively(13.44±3.06)(μg·h)/ml and(14.19±3.28)(μg·h)/ml;their respective AUC 0~∞ were(13.80±3.08)(μg·h)/ml and(14.62±3.33)(μg·h)/ml;their respective C max were(11.65±2.39)μg/ml and(12.37±2.41)μg/ml;their respective t max were(0.57±0.24)h and(0.66±0.19)h.The relative bioavailability of testing preparation was(95.62±13.51)%.CONˉCLUSION:The2preparations are bioequivalent.
Key concepts: Bioequivalence, Bioavailability, Cefaclor, Chromatography, Chemistry, High-performance liquid chromatography, Pharmacokinetics, Pharmacology