A Study of Administration of RoActemra/Actemra (Tocilizumab) by Auto-injector Vs. Pre-filled Syringe in Healthy Volunteers

Sponsor
Hoffmann-La Roche
Study ID
NCT01418989
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteer

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

Start date
Jul 31, 2011
Status verified
Nov 2016
Primary completion
Nov 30, 2011
Completion
Nov 30, 2011

Study Design

Enrollment
239 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1
  • Experimental: 2

Primary Outcome Measure

Area under the plasma concentration versus time curve (AUC) of RoActemra/Actemra [ Time Frame: 21 days ]

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