Clinical Data Neditol 2018-05-10T12:33:06+00:00



Clinical Data

Neditol? XL meets all the relevant regulatory requirements of a bioequivalent medicine (reference product Detrusitol? XL 2mg and 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

Neditol03Reference: 1) Data on file. 1010067149 v 1.0 June 2016.

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Adverse events should be reported. Reporting forms and information can be found at
Adverse events should also be reported to Aspire Pharma Ltd on 01730 231148
For more information about Neditol XL, please see the abbreviated prescribing information.
Revision reference – Neditol XL_16__27/02/2017