Bioequivalence Studies of 2 Oral Cefaclor Capsule Formulations in Chinese Healthy Subjects

Abstract

An open-label, single-dose, randomized, crossover study was carried out in 20 Chinese healthy male subjects to compare the pharmacokinetics of 2 cefaclor (CAS 53994-73-3) formulations after administration of a single 250 mg dose of each drug with a 1-week wash-out period. Blood samples were collected before and with 6 h after drug administration. Plasma concentrations were determined by high-performance liquid chromatography (HPLC) with UV detector. 2 formulations were evaluated using the following pharmacokinetic parameters: AUC_0–t, C_max and t_max was analyzed nonparametrically. The 90% confidence interval (CI) of the ratios (teat/reference) of log-transformed AUC_0–t and C_max fell within the bioequivalence acceptance range of 80–125%. The results showed that the 90% CI of the ratios of AUC_0–t and C_max were 105.1% (101.0–109.4%) and 92.4% (82.5–103.4%), respectively, which therefore could conclude 2 oral cefaclor capsule formulations of cefaclor are bioequivalent. Both treatments showed similar tolerability and safety.

Key words

antibiotics - cefaclor - CAS53994-73-3 - pharmacokinetics - bioequivalence - HPLC

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