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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02246855 on ClinicalTrials.gov