Bioequivalence and Bioavailability Forum

Dear HS,

❝ Do you mean, the upper CL of C_max in the fed study is higher than the upper CL of C_max in the fasting study -

Yes. the upper CL of C_max fed is higher than the Upper CL of C_max fasting study.


And the data of fasting and fed is mentioned below:

Fasting study:

90% CI of AUC_0-t, AUC_0-inf and C_max are 99.88 to 117.06, 98.50 to 113.52 and 96.51 to 121.54 respectively.
GMRatio: AUC_0-t, AUC_0-inf and C_max are 108.13, 105.74 and 108.31 respectively.

Fed study:

90% CI of AUC_0-t, AUC_0-inf and C_max are 98.92 to 141.62, 105.20 to 140.79 and 98.34 to 154.01 respectively.
GMRatio: AUC_0-t, AUC_0-inf and C_max are 118.36, 121.70 and 123.06 respectively.

here the CV_intra of fasting and fed conditions are 24.65 and 50.04 respectively for C_max.

But according to the label the innovator had done the study in fasting conditions only. But according to the statement of the innovator that the Cmax of the drug will increase in fed condition is it implies that the sample size is small when compared to fasting condition. but we had take same sample size for both the studies (28).

Thank you very much for your explanation.