Bioequivalence and Bioavailability Forum

Dear DIXIT,

❝ Now my question is if glucose solution is administered the blood glucose levels will increase. Will this effect the study performance.

No there will be no effect on the study performance.

❝ can we continue that subject in study or withdraw him from the study. Because the glucose levels may increase because of this additional administering of glucose solution.

We can continue the subject in the study as we are giving the glucose solution to increase the glucose level and after that we are giving the acarbose tablet to reduce those levels at which dosage (like 25mg, 50mg, 75mg or 100mg), as this study is doing as an escalation study. And one more thing is that you have to relax the parameters in the I/E criteria if necesaary before the protocol approval.

Already we had done the Acarbose study. According to the FDA recommendation, we have to claim the BE with the dissolution tests itself w.r.t to the FDA given parameters. Another method which was given by the FDA itself is that we have to do the study with Pharmacodynamic dose escalation study to find out out at which dosage the acarbose is restricting the glucose levels.

May be this helps.

Thank you,