Bioequivalence Study of Sustained-Release Tablets

A generic drug (generic drugs, short: generics) is a drug which is produced and distributed without patent protection. The generic drug may still have a patent on the formulation but not on the active ingredient. Based on clinical, pharmacokinetic and statistical data obtained from 18 subjects normal, adult, human subjects under fasting conditions, it was concluded that both the formulations were well tolerated following a single dose administration of the investigational product and test formulation was found to be bioequivalent to the reference formulation the 90% confidence intervals for the means of the primary efficacy variables; AUC0-t,Cmax and AUC0- determined.