Neditol® XL meets all the relevant regulatory requirements of a bioequivalent medicine (reference product Detrusitol® (tolterodine) XL 4mg prolonged release capsules).1 Three bioequivalence clinical trials were performed comparing Detrusitol Retard 4mg (Pfizer Italy, Rome, Italy). Two single dose studies were performed under fed and fasted conditions and a steady state study was performed under fasted conditions.1 The graphs are shown below.1
Single dose Study Comparing Neditol XL 4mg and Detrusitol Retard 4mg Under Fasting Conditions1
Single Dose Study Comparing Neditol XL 4mg and Detrusitol Retard 4mg Under Fed Conditions1
Steady state study comparing Neditol XL 4mg and Detrusitol retard 4mg under fasting conditions1
Reference: 1) Data on file. 1010067149 v 4.0 October 2019.