Bioequivalence of cefaclor suspension in healthy volunteers
Sui Miao
Abstract
Sui Miao
Abstract
Objective:To study the bioequivalence of the test and reference cefaclor suspensions-in 20 male healthy volunteers.Methods:Single oral doses(750 mg)of two cefaclor suspensions were given to 20 healthy volunteers in a randomized cross-over study.The concentration of cefaclor in plasma was determined by HPLC.Re- suits:For the test and reference cefaclor suspensions,t_(1/2)were(1.519±0.807)and(1.631±0.808)h;C_(max) were(5.858±1.614)and(5.850±1.715)μg·mL~(-1);T_(max)were(0.516±0.138)and(0.546±0.155)h; AUC_(0-t)were(7.184±1.919)and(7.133±1.758)μg·h·mL~(-1).The relative bioavailability of AUC_(0~6)was (101.4±15.3)%.Conclusion:Two preparations of cefaclor suspension were bioequivalent in health volunteers as confirmed by statistical analysis.
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Objective:To study the bioequivalence of the test and reference cefaclor suspensions-in 20 male healthy volunteers.Methods:Single oral doses(750 mg)of two cefaclor suspensions were given to 20 healthy volunteers in a randomized cross-over study.The concentration of cefaclor in plasma was determined by HPLC.Re- suits:For the test and reference cefaclor suspensions,t_(1/2)were(1.519±0.807)and(1.631±0.808)h;C_(max) were(5.858±1.614)and(5.850±1.715)μg·mL~(-1);T_(max)were(0.516±0.138)and(0.546±0.155)h; AUC_(0-t)were(7.184±1.919)and(7.133±1.758)μg·h·mL~(-1).The relative bioavailability of AUC_(0~6)was (101.4±15.3)%.Conclusion:Two preparations of cefaclor suspension were bioequivalent in health volunteers as confirmed by statistical analysis.
Key concepts: Cefaclor, Bioequivalence, Bioavailability, Pharmacokinetics, Medicine, Chromatography, Pharmacology, Chemistry