A phase I, randomized, Double-blind, single-dose pharmacokinetic study to evaluate the biosimilarity of SB16 (proposed denosumab biosimilar) with reference denosumab in healthy male subjects

CONCLUSION: Thisstudy demonstrated PK bioequivalence between SB16, EU-DEN, and US-DEN inhealthy male subjects.TRIALREGISTRATION: CT.gov identifier:NCT04621318.PMID:37870163 | DOI:10.1080/13543784.2023.2273510
Source: Expert Opinion on Investigational Drugs - Category: Drugs & Pharmacology Authors: Source Type: research