Objective:To evaluate the bioequivalence and pharmacokinetics of cefixime granules and capsules in Chinese healthy volunteers. Methods: An open randomized, three periods cross over study was adopted recruiting 24 healthy male volunteers. Each volunteer was randomly administered a single oral dose of 200 mg cefixime (test or reference samples). The plasma concentration of cefixime was determined by HPLC-MS/MS. Non-compartment model was used in the analysis of pharmacokinetic parameters. Logarithm-transformed Cmax and AUC were analyzed by the analysis of variance and 90% confidence intervals. Results: Cmax of the test cefixime granules, capsules and the reference capsules was (4003.04 ±2015.76), (3673.04 ±2 056.62) and (3 654.35 ± 1 591.03) μg · L-1, respectively, and tmax was(3.46 ±0.81) , (3.74±1.35)and (3. 57 ±0. 41) h, respectively. T1/2 was (3.96± 0.88) ,(4.47 ±1.26) and (3. 95 ±0. 91) h, respectively. AUC0→24 was (30 860.92 ±13 372.82) , (28 155.24 ± 12 893.08) and (27 401.47 ± 12 222.24) μg · h · L-1, respectively. AUC0→∞ was ( 31 555. 52 ± 13 564. 27 ),( 29 111. 76 ± 13 058. 72 ) and (27 960.22 ± 12 255. 11) μg · h · L-1 , respectively. Conclusion: The test cefixime granules and capsules are both bioequivalent with the reference capsules.
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NSTL
维普
万方数据
