A randomized, open-label, single dose, 2-way crossover bioequivalence study comparing ticagrelor 90 mg hard capsules (PG402 [Celon Pharma]) vs ticagrelor 90 mg film-coated tablets (Brilique [AstraZeneca AB]) under fasting conditions in healthy volunteers

Start 17 Oct 2023 · End 14 Dec 2023 · Status Ended · 1 EU/EEA countries · 1 sites · Protocol 01TICA2023

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Bioequivalence study

Status Ended

Participants planned 40

Countries 1

Sites 1

Prevention of atherothrombotic events in adult patients with - acute coronary syndromes (ACS) or - a history of myocardial infarction (MI) and a high risk of developing an atherothrombotic event

Key facts

Sponsor: Celon Pharma S.A.
Participant type: Healthy volunteers
Age range: 18-64 years
Gender: Male and Female
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trial duration: 17 Oct 2023 → 14 Dec 2023
Decision date (initial): 2023-10-16
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

Prevention of atherothrombotic events in adult patients with - acute coronary syndromes (ACS) or - a history of myocardial infarction (MI) and a high risk of developing an atherothrombotic event

Version	Level	Code	Term	System organ class
20.0	PT	10028596	Myocardial infarction	100000004849

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Celon Pharma S.A.

Sponsor organisation: Celon Pharma S.A.
Address: Ul. Ogrodowa 2a, Kielpin Kielpin
City: Lomianki
Postcode: 05-092
Country: Poland

Scientific contact point

Organisation: Celon Pharma S.A.
Contact name: Clinical Trial Department

Public contact point

Organisation: Celon Pharma S.A.
Contact name: Clinical Trial Department

Locations

1 EU/EEA country · 1 investigational sites

By country

Country	MS status	Planned subjects	Sites
Poland	Ended	40	1
Rest of world	—	0	—

Investigational sites

Poland

1 site · Ended

Bioresearch Group Sp. z o.o.

BioResearch, Ul. Sokolowska 9/u2, 01-142, Warsaw

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
Poland	2023-10-17	2023-12-14	2023-10-29	2023-11-04

Application history

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

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2023-06-21	Poland	Acceptable 2023-10-09	2023-10-16