Single-Dose Study to Compare the Pharmacokinetics, Safety, and Tolerability of Three Formulations of Infliximab (CT-P13, EU-sourced Infliximab and US-sourced Infliximab) in Healthy Volunteers

Trial Profile

Single-Dose Study to Compare the Pharmacokinetics, Safety, and Tolerability of Three Formulations of Infliximab (CT-P13, EU-sourced Infliximab and US-sourced Infliximab) in Healthy Volunteers

Completed
Phase of Trial: Phase IV

Latest Information Update: 11 May 2015

At a glance

  • Drugs Infliximab (Primary)
  • Indications Ankylosing spondylitis; Plaque psoriasis; Psoriatic arthritis; Rheumatoid arthritis; Ulcerative colitis
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Celltrion
  • Most Recent Events

    • 11 May 2015 Pharmacokinetic bioequivalence following single dose administration Primary endpoint considered met.
    • 11 May 2015 New trial record
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