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

NCT02053753 Phase 1 COMPLETED Results posted

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.

Details

Lead sponsor	Amgen
Phase	Phase 1
Status	COMPLETED
Enrolment	146
Start date	2014-02
Completion	2014-08

Conditions

• Healthy Volunteer

Interventions

• Denosumab CP4
• Denosumab CP2

Primary outcomes

• Maximum Observed Drug Concentration (Cmax) of Denosumab — Day 1 predose up to day 127
  Serum denosumab concentration-time data were analyzed by non-compartmental methods. Serum concentrations below the LLOQ (20.0 ng/mL) were set to 0 before data analysis.
• Area Under the Drug Concentration-time Curve From Time 0 to 18 Weeks Post-dose (AUC0-18 Weeks) of Denosumab — Day 1 predose up to day 127
  Serum denosumab concentration-time data were analyzed by non-compartmental methods. Serum concentrations below the LLOQ (20.0 ng/mL) were set to 0 before data analysis.

Countries

United States