A single-dose, open-label, randomized, two-period, two-sequence, crossover pivotal bioequivalence study on two amoxicillin-clavulanic acid film-coated tablet formulations in healthy volunteers under fed conditions.

Start 28 Jul 2025 · End 17 Dec 2025 · Status Ended · 1 EU/EEA countries · 1 sites · Protocol 01-AMO-CLA-BIO-25

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Bioequivalence study

Status Ended

Participants planned 56

Countries 1

Sites 1

infections

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] - Bacterial Infections and Mycoses [C01]
Trial duration: 28 Jul 2025 → 17 Dec 2025
Decision date (initial): 2025-07-15
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

infections

Version	Level	Code	Term	System organ class
20.0	HLT	10005940	Bone and joint infections	10021881
20.0	LLT	10001102	Acute upper respiratory infections of multiple or unspecified sites	10021881

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: clinical department

Public contact point

Organisation: Tarchominskie Zaklady Farmaceutyczne Polfa S.A.
Contact name: clinical department

Locations

1 EU/EEA country · 1 investigational sites

By country

Country	MS status	Planned subjects	Sites
Czechia	Ended	56	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	2025-07-28	2025-12-17	2025-07-28	2025-08-14

Application history

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

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2025-06-10	Czechia	Acceptable 2025-06-27	2025-07-15