NCT05883124

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

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) (Luye Pharma AG, Germany) Compared to the Reference Patch Exelon® 9.5 mg/24 h (Once-daily Patch) (LTS Lohmann Therapie-Systeme AG, Germany) Applied for 11 Days

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (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 marketed Test product Rivastigmine twice-weekly 9,5 mg/24 h transdermal patch (Manufacturer: Luye Pharma AG, Germany) and the marketed Reference product Exelon® 9.5 mg/24 h transdermal patch (Manufacturer: LTS Lohmann Therapie-Systeme AG, Germany) after multiple patch applications. Each of both treatments will last for 11 days with a washout period of at least 14 treatment-free days between the treatments.

Conditions

• Bioequivalence

Interventions

Type	Name	Description
DRUG	Rivastigmine twice-weekly 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: 2023-04-17
• Primary completion: 2023-06-19
• Completion: 2023-07-21
• First posted: 2023-05-31
• Last updated: 2024-02-02

Locations

1 site across 1 country: Germany