NCT00845663

Comparison Bioequivalence Study: Pre-filled Syringe (Reference) Versus Auto-injection Device (Test)

Open Label, Randomized, Parallel Group, Single Dose, 2-way Comparison Bioequivalence Study of Certolizumab Pegol Solution Injected Either by a Pre-filled Syringe (Reference) or by an Auto-injection Device (Test) to Healthy Volunteers.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

To compare the bioavailability of a single 400 mg dose of certolizumab pegol solution (2 x 200mg subcutaneous injections) injected either by a pre-filled syringe (reference) or by an auto-injection device (test).

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Certolizumab pegol	Auto-injection device (test) containing 1 mL of certolizumab pegol liquid formulation, 200 mg/mL; 2 injections
DRUG	Certolizumab pegol	Pre-filled syringe (reference) containing 1 mL of certolizumab pegol liquid formulation, 200 mg/mL; 2 injections

Timeline

• Start date: 2007-10-01
• Primary completion: 2008-04-01
• Completion: 2008-04-01
• First posted: 2009-02-18
• Last updated: 2011-08-31
• Results posted: 2009-11-17

Locations

1 site across 1 country: France