TROIKA-1: A double-blind, randomized, parallel group, study aimed to demonstrate the equivalent pharmacokinetic profile of HD201, a potential biosimilar candidate to trastuzumab, versus EU-Herceptin
biosimilar
pharmacokinetic
trastuzumab
Journal
Pharmacology research & perspectives
ISSN: 2052-1707
Titre abrégé: Pharmacol Res Perspect
Pays: United States
ID NLM: 101626369
Informations de publication
Date de publication:
08 2021
08 2021
Historique:
received:
07
03
2021
accepted:
20
03
2021
entrez:
26
7
2021
pubmed:
27
7
2021
medline:
12
2
2022
Statut:
ppublish
Résumé
Prestige Biopharma Ltd (Singapore) has developed HD201, a proposed biosimilar to reference product trastuzumab. As a part of the stepwise approach to ensure comparability between the biosimilar candidate and the reference medicinal product, a phase I study in healthy subjects was conducted to demonstrate the pharmacokinetic (PK) equivalence (NCT03776240). The primary objective of the study was to demonstrate (PK) equivalence of HD201, EU-Herceptin
Identifiants
pubmed: 34309241
doi: 10.1002/prp2.839
pmc: PMC8311913
doi:
Substances chimiques
Antibodies
0
Antineoplastic Agents, Immunological
0
Biosimilar Pharmaceuticals
0
Trastuzumab
P188ANX8CK
Banques de données
ClinicalTrials.gov
['NCT03776240']
Types de publication
Clinical Trial, Phase I
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e00839Subventions
Organisme : Prestige Biopharma Ltd
Informations de copyright
© 2021 The Authors. Pharmacology Research & Perspectives published by British Pharmacological Society and American Society for Pharmacology and Experimental Therapeutics and John Wiley & Sons Ltd.
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