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An open label, randomized, crossover, two-period, two-sequence, single dose study to assess the relative bioavailability of Rotigotine 4.5 mg (2 mg/24 hrs) transdermal patch (Test Product) compared to Neupro® 2 mg/24 h Transdermal Patch (Reference product) in 48 healthy adult volunteers under fasting conditions.

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515840-21-00
Acronym
987/24
Enrollment
48
Registered
2024-09-06
Start date
2024-09-30
Completion date
2024-10-14
Last updated
2024-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Not applicable (submitted trial is a bioavailability study in healthy subjects).

Interventions

None listed

Sponsors

Eva Pharma For Pharmaceuticals And Medical Appliances SAE
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Countries

Czechia

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026