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

NCT02053753 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2017-12-29

Study results available
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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

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.

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02053753 on ClinicalTrials.gov