title: 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: AUC0-t, AUC0-∞ and C max. The 90% confidence interval (CI) of the ratios of log-transformed AUC0-t and AUC0-∞ 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 AUC0-t, AUC0-∞ 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.
authors.affiliation: School of Medicine, Zhejiang University, Hangzhou, People's Republic of China.
authors.forename: J
authors.initials: J
authors.lastname: Chen
authors.forename: B
authors.initials: B
authors.lastname: Jiang
authors.forename: H
authors.initials: H
authors.lastname: Lou
authors.forename: L
authors.initials: L
authors.lastname: Yu
authors.forename: Z
authors.initials: Z
authors.lastname: Ruan
mesh_terms: D000328:Adult; D000900:Anti-Bacterial Agents / Q000493:pharmacokinetics*; D019540:Area Under Curve; D000077525:Cefdinir; D002511:Cephalosporins / Q000493:pharmacokinetics*; D002851:Chromatography, High Pressure Liquid; D018592:Cross-Over Studies; D005215:Fasting / Q000378:metabolism*; D006801:Humans; D008297:Male; D011786:Quality Control; D013810:Therapeutic Equivalency
chemical_list: D000900:Anti-Bacterial Agents; D002511:Cephalosporins; D000077525:Cefdinir