Bioequivalence Estimation of Two Formulations of Cefixime Tablets among Healthy Chinese Volunteers under Fasting Condition

Abstract

Objective: To assess the bioequivalence of 200mg Cefixime tablets after oral administration to healthy adults under fasting condition. Method: This study was an open-label, balanced, randomized singledose, two-treatment, two-sequence, two-period, crossover oral bioequivalence study in healthy adult, human subjects under fasting condition. Subjects were fasted overnight for at least 10.00 hours before scheduled time of start of dosing. Investigational Product, one tablet of the test formulation or one tablet of reference formulation (allocated as per the randomization schedule) was administered orally to each subject. The pharmacokinetic parameters maximum plasma concentration (Cmax), area under the plasma concentration-time curve (AUC0-t), AUC extrapolated to infinity (AUC0-8) was estimated to prove bioequivalence. Acceptance range for bioequivalence was 80.00%-125.00% for 90% confidence intervals of the geometric least square means ratio for Cmax, AUC0-t and AUC0-8. Results: For the test formulation, the Cefixime Mean Cmax was 3891.31ng/ mL (vs. 3676.32ng/mL for reference), AUC0-t was 33299.52ng•h/mL (vs. 32182.07ng•h/mL) and AUC0-8 was 34234.88ng•h/mL (vs. 33162.95ng•h/mL). The 90% confidence intervals for the Geometric Least Squares Means ratios for Cefixime were 105.85% (90% CI: 98.73%-113.48%), 103.47% (90% CI: 96.34%-111.13%) and 103.23% (90% CI: 96.28%-110.69%) for Cmax, AUC0-t and AUC0-8 respectively, which are within the acceptance range of 80.00% to 125.00% for pharmacokinetic parameter Cmax, AUC0-t and AUC0-8 required for concluding bioequivalence between the test and reference formulations. There were no deaths or serious adverse events during the conduct of the study. Conclusion: Test product when compared with the reference product meets the bioequivalence criteria in terms of rate and extent of absorption of cefixime after administration of single dose under fasting condition.