Bioequivalence of mirabegron 50 mg extended release Tablet [Design Issues]

posted by Ibrahim Komeil – Egypt, 2021-02-20 10:36 (115 d 21:27 ago) – Posting: # 22218
Views: 822

Dear All
I had performed a 2X2 crossover study between test and reference product of mirabegron 50 mg under fasting conditions where 34 volunteers were completed the study.

Knowing that I couldn't find an accurate data for intrasubject variability of Mirabegnon. The results showed a very high unexpected intra-subject variability as following:
Cmax: 73.8451%, AUCt: 67.6524%
I calculated study power too and it results as following:
Cmax: 38.45% and AUCt: 42.38%

Therefore, a sequential two stage study won't be applicable in that condition. My question is: If i repeat the aforementioned study again, shall i follow a partial replicated cross over design or full replicated cross over design?

My second: Shall i follow RASBE or unscaled BE limits ?

Thanks in advance

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