A single-dose, open-label, randomized, two-period, two-sequence, crossover pivotal bioequivalence study on Dapagliflozin 10 mg film-coated tablets (Polfa Tarchomin S.A., Poland) versus Froxiga 10 mg film-coated tablets (AstraZeneca AB, Sweden) in healthy volunteers under fasting conditions.

Start 3 Apr 2025 · End 4 Jun 2025 · Status Ended · 1 EU/EEA countries · 1 sites · Protocol 01-DAP-BIO-24

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Bioequivalence study

Status Ended

Participants planned 36

Countries 1

Sites 1

intended for treatment of for the treatment of (2): • insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise. • symptomatic chronic heart failure. • chronic kidney disease.

Key facts

Sponsor: Tarchominskie Zaklady Farmaceutyczne Polfa S.A.
Participant type: Healthy volunteers
Age range: 18-64 years
Gender: Male and Female
Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trial duration: 3 Apr 2025 → 4 Jun 2025
Decision date (initial): 2025-03-27
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: No

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Version	Level	Code	Term	System organ class
21.1	LLT	10045252	Type II diabetes mellitus without mention of complication	10027433

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Tarchominskie Zaklady Farmaceutyczne Polfa S.A.

Sponsor organisation: Tarchominskie Zaklady Farmaceutyczne Polfa S.A.
Address: Ul. Aleksandra Fleminga 2
City: Warsaw
Postcode: 03-176
Country: Poland

Scientific contact point

Organisation: Tarchominskie Zaklady Farmaceutyczne Polfa S.A.
Contact name: Ilona Łojszczyk, PhD Eng.

Public contact point

Organisation: Tarchominskie Zaklady Farmaceutyczne Polfa S.A.
Contact name: Ilona Łojszczyk, PhD Eng.

Locations

1 EU/EEA country · 1 investigational sites

By country

Country	MS status	Planned subjects	Sites
Czechia	Ended	36	1
Rest of world	—	0	—

Investigational sites

Czechia

1 site · Ended

Cepha s.r.o.

clinic, Komenskeho 19, Severni Predmesti, Plzen 1

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	2025-04-03	2025-06-04	2025-04-03	2025-04-11

Application history

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

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2025-02-21	Czechia	Acceptable 2025-03-25	2025-03-27