Conditions: Healthy
Keywords: certolizumab pegol Cimzia bioequivalence Comparison Bioequivalence Study
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 98
Healthy volunteers: yes

Brief 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).

Detailed description:

Arms:
arm 1: pre-filled syringe (reference) arm 2: Auto-injection device (test)

Interventions: intervention 1: Certolizumab pegol intervention 2: Certolizumab pegol
Intervention descriptions: intervention 1: Auto-injection device (test) containing 1 mL of certolizumab pegol liquid formulation, 200 mg/mL; 2 injections intervention 2: Pre-filled syringe (reference) containing 1 mL of certolizumab pegol liquid formulation, 200 mg/mL; 2 injections

Protocol document: