The purpose of this study was to evaluate whether test cefradine capsules and reference cefradine capsules were bioequivalent in healthy Chinese volunteers. An open-label, randomized, biperiodic, crossover design was used. In each of the 2 study periods (separated by a 1-week washout period), 250-mg single doses of either the test or reference cefradine capsule were administered to study participants under fasted and fed conditions. Blood samples were collected at intervals from predose to 8 hours afterward. In the fasting study, the 90% confidence intervals (90%CI) of the Cmax , AUC0-8h , and AUC0-∞ for the test and reference preparations were 93.7%-112.2%, 94.6%-100.8%, and 94.7%-100.9%, respectively. In the fed study, the 90%CI of the Cmax , AUC0-8h , and AUC0-∞ for the test and reference preparations was 81.0%-99.1%, 100.5%-106.3%, and 100.5%-105.9%, respectively. The results showed that the test cefradine capsules and the reference formulation are bioequivalent under both fasting and fed conditions.
Keywords: bioequivalent; cefradine capsules; cephalosporin antibiotic; pharmacokinetics; safety.
© 2021, The American College of Clinical Pharmacology.