The pivotal bioequivalence study comparing the test product to the reference product, which belong to the group of medicines used in the treatment of type 2 diabetes mellitus when the condition cannot be adequately controlled by diet and exercise alone.

Start 29 Sep 2025 · End 16 Dec 2025 · Status Ended · 1 EU/EEA countries · 1 sites · Protocol 1048/25

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Bioequivalence study

Status Ended

Participants planned 44

Countries 1

Sites 1

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

Key facts

Sponsor: Adamed Pharma S.A.
Participant type: Healthy volunteers
Age range: 18-64 years
Gender: Male and Female
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18], Diseases [C] - Cardiovascular Diseases [C14]
Trial duration: 29 Sep 2025 → 16 Dec 2025
Decision date (initial): 2025-09-08
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

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

Version	Level	Code	Term	System organ class
23.1	PT	10064848	Chronic kidney disease	100000004857
28.0	PT	10067585	Type 2 diabetes mellitus	100000004861
20.0	PT	10007554	Cardiac failure	100000004849

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Adamed Pharma S.A.

Sponsor organisation: Adamed Pharma S.A.
Address: Ul. Mariana Adamkiewicza 6a, Pienkow Pienkow
City: Czosnow
Postcode: 05-152
Country: Poland

Scientific contact point

Organisation: Adamed Pharma S.A.
Contact name: Pharmacokinetic Study Team

Public contact point

Organisation: Adamed Pharma S.A.
Contact name: Pharmacokinetic Study Team

Locations

1 EU/EEA country · 1 investigational sites

By country

Country	MS status	Planned subjects	Sites
Czechia	Ended	44	1
Rest of world	—	0	—

Investigational sites

Czechia

1 site · Ended

Quinta-Analytica s.r.o.

Clinic, Prazska 1486/18c, Hostivar, Prague

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
Czechia	2025-09-29	2025-12-16	2025-10-13	2025-10-25

Application history

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

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2025-08-18	Czechia	Acceptable 2025-09-08	2025-09-08
2	NON SUBSTANTIAL MODIFICATION	NSM-1	2025-11-24	Czechia	Acceptable 2025-09-08	2025-11-24