Aim: Bioequivalence study of etodolac ER tablets 600mg under fasting condition.
METHOD: Normal healthy adult male human subjects received either 600mg of the reference or test formulation in fasting (N=12) condition. The study was conducted according to a single dose and randomized crossover design. Blood samples were collected upto 48.00hours after drug administration. Plasma concentrations of Etodolac were determined by LC-MS/MS. Pharmacokinetic parameters were calculated from the observed plasma concentration- time profiles. Bioequivalence between the formulations were found out considering 90% confidence interval for the ratio of means for Cmax, AUC0-inf and AUC0-t within 80-125%.
Results: The 90% confidence interval for the test, the ratio of the means for Cmax (92.09-119.66), AUC0-inf (98.22-117.6) and AUC0-t (92.70-110.21) and was within the guidelines range of bioequivalence (80-125%).
Conclusion: So based on results we can conclude that the pilot study of Etodolac Tablet was performed with high accuracy with compliance of all the regulatory requirements. Based on the statistical analysis test products of Etodolac ER tablets 600mg of sponsor’s formulation is bioequivalent to Reference product Etodolac ER tablets 600mg in terms of rate and extent under fasting condition. So, the formulation of the test product is passing the study and with the higher sample size in the pivotal study will also give positive results.
