A Comparison of the Pharmacokinetics, Safety and Tolerance of Two Formulations of a Liquid IVIg in Healthy Volunteers
NCT02246855 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL
Last updated 2018-02-27
Summary
The main object of the study is to compare the AUC0-84, of a single intravenous infusion of Vigam® Liquid (infused at the licensed rate of up to 3mL/min) with Gammaplex® (infused at up to 3mL/min and up to 6mL/min).
Conditions
- Healthy
Interventions
- BIOLOGICAL
-
Gammaplex® (Human Normal Immunoglobulin)
Sponsors & Collaborators
-
Bio Products Laboratory
lead OTHER
Principal Investigators
-
David Wessels, MBChB MBA
Study Design
- Purpose
- TREATMENT
Eligibility
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2004-08-31
- Primary Completion
- 2004-12-31
Countries
- United Kingdom
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