A bioequivalence study comparing Empagliflozin 25 mg film-coated tablets, VIANEX S.A., Greece versus Jardiance 25 mg film-coated tablets, Boehringer Ingelheim International GmbH, Germany, in healthy male and female volunteers under fasting conditions.

Start 9 Mar 2026 · End 24 Mar 2026 · Status Ended · 1 EU/EEA countries · 1 sites

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Bioequivalence study

Status Ended

Participants planned 36

Countries 1

Sites 1

none - healthy volunteers

Key facts

Sponsor: Vianex S.A.
Participant type: Healthy volunteers
Age range: 18-64 years
Gender: Male and Female
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trial duration: 9 Mar 2026 → 24 Mar 2026
Decision date (initial): 2026-02-18
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

none - healthy volunteers

Version	Level	Code	Term	System organ class
20.0	LLT	10000803	Acute heart failure	10007541
20.0	LLT	10012594	Diabetes	10027433

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Vianex S.A.

Sponsor organisation: Vianex S.A.
Address: Varibobi Street 8
City: Nea Erythrea
Postcode: 146 71
Country: Greece

Scientific contact point

Organisation: Vianex S.A.
Contact name: clinical department

Public contact point

Organisation: Vianex S.A.
Contact name: clinical department

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	2026-03-09	2026-03-24	2026-03-09	2026-03-13

Application history

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

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2026-01-14	Czechia	Acceptable 2026-02-03	2026-02-18