Bioequivalence and Bioavailability Forum

Dear All,

According to Draft Guidance on Acarbose, a pilot study should first be conducted to determine the appropriate dose for the pivotal BE study. The first dose tested should be the RLD 1*25mg tablet.

The sponsor has two strengths of 50 mg and 100 mg.

Since the sponsor does not have 25 mg, can we start with 100 mg and revert back to 50 mg if we see effect in 100 mg ? We search the literature and found that the effect could hardly be seen in 50mg. The sponsor suggests to run 100 mg first. If no effect, proceeds to 150 mg.

Your comment is highly appreciated.

Thank you.

Regards,
Ken

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Edit: Guidance linked. [Helmut]