NCT03573050

Rivastigmine BA Trial With Multiple Application of Transdermal Patches, Adaptation and Tapering Phase

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: SocraTec R&D GmbH · Academic / Other
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Bioequivalence

Interventions

Type	Name	Description
DRUG	RIV-TDS 13.3 mg/24 h	5 consecutive transdermal patch applications, each with a nominal release rate of 13.3 mg/24 hours
DRUG	Exelon® 13.3 mg/24 hours transdermal patch	5 consecutive transdermal patch applications, each with a nominal release rate of 13.3 mg/24 hours

Timeline

• Start date: 2018-05-16
• Primary completion: 2018-07-05
• Completion: 2018-07-05
• First posted: 2018-06-29
• Last updated: 2018-08-21

Locations

1 site across 1 country: Germany