NCT02053753

Bioequivalence Study of Denosumab CP4 Drug Product and Commercially Available Denosumab CP2 Drug Product

A Double-Blind, Randomized, Single-Dose, Parallel-Group Study in Healthy Volunteers to Assess the Bioequivalence of a 120 mg Denosumab Subcutaneous Dose When Administered as Denosumab CP4 Drug Product or as Commercially Available Denosumab CP2 Drug Product

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 146 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

To evaluate the bioequivalence based on pharmacokinetics (PK) of a single 120 mg subcutaneous dose of denosumab administered to healthy volunteers using denosumab CP4 or denosumab CP2 drug products.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	Denosumab CP4	Denosumab produced by a process referred to as CP4, administered subcutaneously.
DRUG	Denosumab CP2	Denosumab produced by a process referred to as CP2, administered subcutaneously.

Timeline

• Start date: 2014-02-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2014-02-04
• Last updated: 2017-12-29
• Results posted: 2017-12-29

Locations

2 sites across 1 country: United States