A Randomised, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Denosumab (SB16, EU Sourced Prolia, and US Sourced Prolia) in Healthy Male Subjects
Latest Information Update: 18 Oct 2023
At a glance
- Drugs Denosumab (Primary)
- Indications Osteoporosis; Postmenopausal osteoporosis
- Focus Pharmacokinetics
- Sponsors Samsung Bioepis
- 15 Oct 2023 Primary endpoint (Cmax) has been met, according to a Samsung Bioepis media release.
- 15 Oct 2023 Primary endpoint (AUClast) has been met, according to a Samsung Bioepis media release.
- 15 Oct 2023 Primary endpoint (AUCinf) has been met, according to a Samsung Bioepis media release.