title: 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: AUC0-t, Cmax and tmax was analyzed nonparametrically. The 90% confidence interval (CI) of the ratios (teat/reference) of log-transformed AUC0-t and Cmax fell within the bioequivalence acceptance range of 80-125%. The results showed that the 90% CI of the ratios of AUC0-t and Cmax 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.
authors.affiliation: Division of Clinical of Pharmacology, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, PR 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: D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000737:chemistry / Q000493:pharmacokinetics*; D019540:Area Under Curve; D044466:Asian People; D002214:Capsules; D002433:Cefaclor / Q000008:administration & dosage* / Q000737:chemistry / Q000493:pharmacokinetics*; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid; D018592:Cross-Over Studies; D006207:Half-Life; D006801:Humans; D059625:Liquid-Liquid Extraction; D013810:Therapeutic Equivalency
chemical_list: D000900:Anti-Bacterial Agents; D002214:Capsules; D002433:Cefaclor