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NCT02053753 · ClinicalTrials.gov registry record · Phase 1
Bioequivalence Study of Denosumab CP4 Drug Product and Commercially Available Denosumab CP2 Drug Product
A Phase 1 study of Healthy Volunteer, sponsored by Amgen.
- Completed
- Registry status
- Phase 1
- Development phase
- 146
- Enrollment target
- 2
- Study locations
NCT02053753 is a Phase 1 study of Healthy Volunteer that has completed, run by Amgen. The registered enrollment target is 146 participants, below the 201-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (27% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT02053753, a Phase 1 study of Healthy Volunteer, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 146 participants
- Enrollment target
- 2
- Study locations
Study 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 Studied
Interventions
- DRUG Denosumab CP4
- DRUG Denosumab CP2
Study Locations (2)
California
- Research Site - Cypress
Texas
- Research Site - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 146 participants |
| Start Date | 2014-02 |
| Est. Completion | 2014-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02053753
The ClinicalTrials.gov registry entry for NCT02053753 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 146 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 201-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (27% lower). The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Healthy Volunteer appearing as the primary indexed condition, and to 2 interventions - of which Denosumab CP4 is the first listed.
NCT02053753 reports 2 study locations spanning 2 distinct geographic areas - top geographies include California, Texas.
Frequently Asked Questions
What is clinical trial NCT02053753 about?
NCT02053753 is a clinical study titled "Bioequivalence Study of Denosumab CP4 Drug Product and Commercially Available Denosumab CP2 Drug Product". 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.
What is the current status of trial NCT02053753?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 146 participants. The study started on 2014-02. Estimated completion is 2014-08.
What conditions does trial NCT02053753 study?
This clinical trial studies the following conditions: Healthy Volunteer.
What interventions are being tested in trial NCT02053753?
The interventions under investigation include: Denosumab CP4 (DRUG), Denosumab CP2 (DRUG).
Who is sponsoring clinical trial NCT02053753?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02053753 being conducted?
This trial has 2 study locations across California, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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