Bioequivalence Clinical Trial
Official title:
Multiple Dose Crossover Comparative Bioavailability Study of a Transdermal Patch Formulation of Rivastigmine Compared With Exelon® Transdermal Patch With a Release Rate of 13.3 mg/24 Hours in Healthy Male Subjects With Preceding Adaptation Phase and Post-treatment Tapering Phase
The present clinical trial will be conducted to compare the bioavailability of rivastigmine and assess bioequivalence at steady-state of the Test product RIV-TDS 13.3 mg/24 h and the marketed Reference product Exelon® 13.3 mg/24 hours transdermal patch after multiple patch application. Each of both treatments will last 5 days.
This will be a single centre, open-label, randomised (order of treatments), balanced,
2-period, 2-sequence, cross-over trial with multiple applications of rivastigmine transdermal
patches. There will be no wash-out, i.e. the first investigational patch application of the
second study period will take place the day of the last investigational patch removal of the
first study period (direct switch-over).
Prior to start of first treatment, there will be an adaptation phase with 4 consecutive
applications of Exelon® 9.5 mg/24 hours transdermal patch over a period of 4 days (each patch
will be applied for 24 hours). Following the removal of the last investigational patch in
period II, there will be a post-treatment tapering phase with 2 consecutive applications of
Exelon® 9.5 mg/24 hours transdermal patch over a period of 2 days (each patch will be applied
for 24 hours).
Furthermore, during the adaptation phase, both study periods and the tapering phase,
scopolamine transdermal patches will be applied as co-medication to attenuate effects of
rivastigmine and reduce Adverse Events.
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