Bioequivalence of cefdinir suspension in Chinese healthy volunteers / 中国药学杂志

ABSTRACT

OBJECTIVE: To evaluate the bioequivalence of cefdinir suspension and reference cefdinir capsule in Chinese healthy male subjects. METHODS: A single oral dose of 100 mg cefdinir suspension or cefdinir capsule was given to 24 subjects according to a 2-way crossover design. The plasma concentrations of cefdinir were determined by UPLC-MS/MS. The pharmacokinetic parameters were calculated and bioequivalence was compared by WinNonlin 6.3 program. RESULTS: The main pharmacokinetic parameters of cefdinir suspension and cefdinir capsule were as follow; ρmax were (1034.78±358.17), (969.71±297.38) ng·mL-1; tmax were (2.98±0.60), (3.44±0.70) h; AUC0-12 were (4911.24±1675.30), (4522.35±1600.13) ng·h·mL-1; AUC0-∞ were (5026.24±1735.32), (4680.69±1699.93) ng·h·mL-1;t1/2were (1.71±0.23), (1.79±0.39) h. The 90% confidential interval of ρmax, AUC0-12, AUC0-∞ of tested formulation were 95.6%-115.3%, 99.9%-117.2%, 99.0%-116.0%. CONCLUSION: The two formulations are bioequivalent.