Bioequivalence study of cephradine capsules in Chinese volunteers

摘要

Aim To study the pharmacokinetics and relative bioavailability in humans of test and reference cephradine capsules and to evaluate the equivalence of the two preparations. Methods A reversed-phase high performance liquid chromatography (RP-HPLC) method was developed to determine the plasma concentration of cephradine. 18 male healthy volunteers were given orally a single dose 500 mg of test (T) and reference (R) cephradine capsules in an open randomized two-preparation double-period cross-over design experiment. Pharmacokinetic parameters were obtained from the plasma concentration-time data. Results The main pharmacokinetic parameters of T and R were as follows: AUC_(0_5h) was 1496.68(+-)272.38 mug-mL~(-1)-min~(-1) and 1421.751268.09 mugmL~(-1)-min~(-1); C_(max) 14.41(+-)3.46 ug-mL~(-1) and 14.39(+-)3.62mug-mL~(-1); t_(max) 59.17+15.84 min and 63.33+20.92 min; t_(1/2) 56.69(+-)9.68 min and 54.21+7.53 min, respectively. The relative bioavailability of T to R was 106.3(+-)15.8%. Conclusions The cephradine T and R capsules showed equivalence.