Bioequivalence Evaluation of Cefdinir in Healthy Fasting Subjects

Abstract

A simple and sensitive HPLC method was developed to determine cefdinir (CAS 91832-40-5) in human plasma. The method was validated by investigating the accuracy and precision for intra- and inter-day runs in a linear concentration from 0.05–2.0 µg/ml. The object of this study was to compare the bioavailability of cefdinir capsule (reference) and cefdinir granule (test) containing 100 mg of cefdinir. A randomized, open-label, single-dose, 2-way crossover bioequivalence study in 20 healthy, Chinese, male subjects was conducted. A 1-week wash-out period was applied. Blood samples were collected before and with 10 h after drug administration. The formulations were compared using the following pharmacokinetic parameters: AUC_0-t, AUC_0-∞ and C _max. The 90% confidence interval (CI) of the ratios of log-transformed AUC_0-t and AUC_0-∞ were used to assess bioequivalence between the 2 formulations using the equivalence interval of 80 and 125%. The results showed that the 90% CI of the ratios of AUC_0-t, AUC_0-∞ and C _max were 102.5% (94.7–111.0%), 103.4% (94.8–112.7%) and 106.4% (97.0–116.7%), respectively, which indicated 2 formulations of cefidinir are bioequivalent. Both treatments showed similar tolerability and safety.

Key words

Cefdinir - HPLC - CAS 91832-40-5 - protein precipitation - pharmacokinetics - bioequivalence

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