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

Trial Profile

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

Completed
Phase of Trial: Phase I

Latest Information Update: 19 Apr 2017

At a glance

  • Drugs Denosumab (Primary)
  • Indications Bone disorders; Bone metastases; Malignant hypercalcaemia; Multiple myeloma; Non-small cell lung cancer; Osteoporosis; Rheumatoid arthritis
  • Focus Pharmacokinetics
  • Sponsors Amgen
  • Most Recent Events

    • 13 Nov 2014 Status changed from recruiting to completed as reported by ClinicalTrials.gov
    • 16 Feb 2014 New trial record
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