INTRODUCTION: The present randomized, two-period, cross-over bioequivalence study compared two soft capsules of etoposide (test and reference formulations), in treating 18 advanced lung cancer patients. MATERIALS AND METHODS: The pharmacokinetic parameters were determined based on the concentrations of etoposide, using HPLC with fluorescence detector. In each of the two study periods, a single dose of test or reference product was administered. The pharmacokinetic parameters assessed included area under the plasma concentration-time curve (AUC(0-12h)) from 0 to 12 hours, AUC(0-T) from time zero to infinity, the peak plasma concentration of the drug (C(max)), time to achieve C(max), and the elimination half-life. RESULTS: Comparison of the test and reference products containing etoposide showed that geometric mean ratios (90% confidence interval (CI)) of AUC(0-T), AUC(0-∞), and C(max) were 99.7% (92.1 - 103.7%), 99.4% (92.3 - 105.2%), and 101.5% (94.2 - 109.6%), respectively. Both AUC and C(max) ratio 90% CI of test and reference formulations were within its acceptable range for bioequivalence. The values of tmax and t1/2 were not found to have a statistically significant difference between the test and the reference drug (p > 0.05). No adverse events occurred in this bioequivalence study. CONCLUSION: The two etoposide soft capsules (the test and reference formulations) were bioequivalent.
RCT Entities:
INTRODUCTION: The present randomized, two-period, cross-over bioequivalence study compared two soft capsules of etoposide (test and reference formulations), in treating 18 advanced lung cancerpatients. MATERIALS AND METHODS: The pharmacokinetic parameters were determined based on the concentrations of etoposide, using HPLC with fluorescence detector. In each of the two study periods, a single dose of test or reference product was administered. The pharmacokinetic parameters assessed included area under the plasma concentration-time curve (AUC(0-12h)) from 0 to 12 hours, AUC(0-T) from time zero to infinity, the peak plasma concentration of the drug (C(max)), time to achieve C(max), and the elimination half-life. RESULTS: Comparison of the test and reference products containing etoposide showed that geometric mean ratios (90% confidence interval (CI)) of AUC(0-T), AUC(0-∞), and C(max) were 99.7% (92.1 - 103.7%), 99.4% (92.3 - 105.2%), and 101.5% (94.2 - 109.6%), respectively. Both AUC and C(max) ratio 90% CI of test and reference formulations were within its acceptable range for bioequivalence. The values of tmax and t1/2 were not found to have a statistically significant difference between the test and the reference drug (p > 0.05). No adverse events occurred in this bioequivalence study. CONCLUSION: The two etoposide soft capsules (the test and reference formulations) were bioequivalent.