The pharmacokinetics and relative bioavailability of levofloxacin hydrochloride capsule in healthy volunteers
Zhiwen Jiang
Abstract
Zhiwen Jiang
Abstract
Objective:To investigate the pharmacokinetics and bioequivalence of levofloxacin hydrochloric capsule.Methods:Twenty healthy subjects took oral levofloxacin hydrochloric capsule in the case.The high performance liquid chromatography(HPLC) method was established to determine blood serum concentration and the bioequivalence of the two formulations were evaluated by the analysis of variance and the two one-sided t-test with DAS1.0.Results: The pharmacokinetic parameters of the testee and references were as follows:t_ 1/2 (5.24±1.58) h and(5.50±2.05) h,C_ max (2.75±0.61) mg/L and(2.55±0.61) mg/L;T_ max (0.99±0.56) h and (1.05 ±0.54) h,AUC_ 0-24 (21.53±3.36) mg·L -1 ·h -1 and(20.61±3.67) mg·L -1 ·h -1 ,AUC_ 0-∞ (23.87±3.92) mg·L -1 ·h -1 and(23.05±4.45) mg·L -1 ·h -1 ,respectively.Relative bioavailability was(108.82±30.75)%.Conclusions:The two preparations are of bioequivalence.
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Objective:To investigate the pharmacokinetics and bioequivalence of levofloxacin hydrochloric capsule.Methods:Twenty healthy subjects took oral levofloxacin hydrochloric capsule in the case.The high performance liquid chromatography(HPLC) method was established to determine blood serum concentration and the bioequivalence of the two formulations were evaluated by the analysis of variance and the two one-sided t-test with DAS1.0.Results: The pharmacokinetic parameters of the testee and references were as follows:t_ 1/2 (5.24±1.58) h and(5.50±2.05) h,C_ max (2.75±0.61) mg/L and(2.55±0.61) mg/L;T_ max (0.99±0.56) h and (1.05 ±0.54) h,AUC_ 0-24 (21.53±3.36) mg·L -1 ·h -1 and(20.61±3.67) mg·L -1 ·h -1 ,AUC_ 0-∞ (23.87±3.92) mg·L -1 ·h -1 and(23.05±4.45) mg·L -1 ·h -1 ,respectively.Relative bioavailability was(108.82±30.75)%.Conclusions:The two preparations are of bioequivalence.
Key concepts: Bioequivalence, Pharmacokinetics, Bioavailability, Medicine, Levofloxacin, Capsule, High-performance liquid chromatography, Pharmacology