WHO ICTRP trial

The pivotal bioequivalence study comparing the test product to the reference…

CTIS2025-523325-18-00 · EU Clinical Trials Information System · Not Recruiting

Key facts

Trial ID CTIS2025-523325-18-00
Public title The pivotal bioequivalence study comparing the test product to the reference product, which belongs to the group of medicines used in treatment of schizophrenia in adults patients.
Scientific title - 1053/25
Primary sponsor Adamed Pharma S.A.
Registry EU Clinical Trials Information System
Recruitment status Not Recruiting
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): Yes Therapeutic exploratory (Phase II): No Therapeutic confirmatory - (Phase III): No Therapeutic use - (Phase IV): No
Countries Czechia
Conditions Bioequivalence study under fasting conditions MedDRA version: 20.0Level: PTClassification code: 10039626Term: Schizophrenia Class: 100000004873;Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
Registration date Sep 9, 2025
Target size 36
Registry page euclinicaltrials.eu

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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date:

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