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A Phase 1, multiple-dose, single-center, randomized, open-label, 2-period, 2-treatment crossover systemic bioavailability study of diclofenac comparing XXX g (XXX mL) of AMZ001 (Diclofenac sodium gel XXX %) applied once daily (XXXXXXXXX) versus XXX g of Voltaren Emulgel 1.16% Gel (Diclofenac diethylamine gel 1.16%) applied 4 times daily (4 times 4 g on each knee) in healthy subjects

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515954-26-00
Acronym
AMZ001-009
Enrollment
34
Registered
2024-11-04
Start date
2024-11-19
Completion date
2025-01-22
Last updated
2024-12-17

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

Conditions

Phase I Study in healthy male and female volunteers. Intended indication: acute and chronic musculoskeletal conditions

Interventions

None listed

Sponsors

Amzell B.V.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Countries

Germany

Outcome results

None listed

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