Bioequivalence and Bioavailability Forum

Dear all,

I have a doubt regarding the 90% Confidence Interval, as if the confidence interval limit of Cmax (Fed study) is increased when compared to the fasting study. From this can we say that the absorption of Cmax is high when compared to Reference drug.

But according to the label and literature "In fed conditions the rate and absorption of Cmax will be increased when compared to fasting conditions" but in our study the mean Cmax is decreased when compared to the fasting study, as the mean Cmax of reference is also decreased and less than Test mean Cmax. From this point can we consider that the rate and absorption of Test is better than Reference drug? Please anyone clarify this. Thanks in advance.

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Edit: Category changed. [HS]