NCT03659435

Rivastigmine Bioequivalence Trial With Multiple Application of Transdermal Patches (9.5mg/24h)

Open, Randomized, 2-period, 2-sequence, Cross-over Relative Bioavailability Study to Investigate the Pharmacokinetics and to Assess the Bioequivalence of a Rivastigmine Test Patch Formulation 9.5 mg/24 h (Twice Weekly Patch) Compared to the Reference Exelon® 9.5 mg/24 h (Once Daily Patch) Applied for 11 Days

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: SocraTec R&D GmbH · Academic / Other
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The present clinical trial will be conducted in order to compare the bioavailability of rivastigmine and to assess bioequivalence at steady-state of the Test product RID-TDS 9.5 mg/24 h (Luye Pharma AG, Germany) and the marketed Reference product Exelon® 9.5 mg/24 h transdermales Pflaster (Novartis Pharma GmbH, Germany) after multiple patch application. Each of both treatments will last for 11 days with a washout period of 14 days between the treatments.

Conditions

• Bioequivalence

Interventions

Type	Name	Description
DRUG	RID-TDS 9.5 mg/24 h	3 consecutive applications of 1 patch (1st patch for 4 days, 2nd patch for 3 days, 3rd patch for 4 days) covering an 11-day period
DRUG	Exelon® 9.5 mg/24 h	11 consecutive applications of 1 patch (each patch will be applied for 1 day) covering an 11-day period

Timeline

• Start date: 2018-08-22
• Primary completion: 2018-11-28
• Completion: 2018-11-28
• First posted: 2018-09-06
• Last updated: 2019-09-19

Locations

1 site across 1 country: Germany