A Study of Administration of RoActemra/Actemra (Tocilizumab) by Auto-injector Vs. Pre-filled Syringe in Healthy Volunteers
NCT01418989 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 239
Last updated 2016-11-02
Summary
This open-label, multi-center study will compare the bioavailability of RoActemra/Actemra (tocilizumab) administration by auto-injector versus pre-filled syringe in healthy volunteers. Healthy volunteers will receive a single dose of RoActemra/Actemra (tocilizumab). The anticipated time of study duration is 28 days.
Conditions
- Healthy Volunteer
Interventions
- DRUG
-
tocilizumab [RoActemra/Actemra] Syringe
Single dose administration with pre-filled syringe
- DRUG
-
tocilizumab [RoActemra/Actemra] auto-injector
Single dose administration with auto-injector
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Clinical Trials · Hoffmann-La Roche
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2011-07-31
- Primary Completion
- 2011-11-30
- Completion
- 2011-11-30
Countries
- France
Study Locations
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