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

2024-515954-26-00 Protocol AMZ001-009 Human pharmacology (Phase I) - Other Ended

Start 19 Nov 2024 · End 22 Jan 2025 · Status Ended · 1 EU/EEA countries · 1 sites · Protocol AMZ001-009

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Other

Status Ended

Participants planned 34

Countries 1

Sites 1

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

Key facts

Sponsor: Amzell B.V.
Participant type: Healthy volunteers
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trial duration: 19 Nov 2024 → 22 Jan 2025
Decision date (initial): 2024-11-04
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

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

Version	Level	Code	Term	System organ class
21.0	LLT	10049491	Degenerative joint disease	10028395
20.0	PT	10031161	Osteoarthritis	100000004859
25.1	HLT	10068757	Musculoskeletal and connective tissue pain and discomfort	10028395

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Amzell B.V.

Sponsor organisation: Amzell B.V.
Address: Siriusdreef 31
City: Hoofddorp
Postcode: 2132 WT
Country: Netherlands

Scientific contact point

Organisation: Amzell B.V.
Contact name: Dario Carrara

Public contact point

Organisation: Amzell B.V.
Contact name: Dario Carrara

Locations

1 EU/EEA country · 1 investigational sites

By country

Country	MS status	Planned subjects	Sites
Germany	Ended	34	1
Rest of world	—	0	—

Investigational sites

1 site · Ended

Nuvisan GmbH

Clinical Services, Wegenerstrasse 13, Ludwigsfeld, Neu-Ulm

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country	Trial start	Trial end	Recruitment start	Recruitment end	Early termination
Germany	2024-11-19	2025-01-22	2024-11-19	2024-12-03

Application history

2 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2024-08-26	Germany	Acceptable 2024-10-30	2024-11-04
2	SUBSTANTIAL MODIFICATION	SM-2	2024-11-28	Germany	Acceptable	2024-12-17