A Comparison of the Pharmacokinetics, Safety and Tolerance of Two Formulations of a Liquid IVIg in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Healthy

Study Design

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Primary Study Purpose

TREATMENT

Study Groups

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Vigam® Liquid infused at up to 3mL/min

Gammaplex® (Human Normal Immunoglobulin)

Group Type EXPERIMENTAL

Gammaplex® (Human Normal Immunoglobulin)

Intervention Type BIOLOGICAL

Gammaplex® infused at up to 3mL/min

Gammaplex® (Human Normal Immunoglobulin)

Group Type EXPERIMENTAL

Gammaplex® (Human Normal Immunoglobulin)

Intervention Type BIOLOGICAL

Gammaplex® infused at up to 6mL/min

Gammaplex® (Human Normal Immunoglobulin)

Group Type EXPERIMENTAL

Gammaplex® (Human Normal Immunoglobulin)

Intervention Type BIOLOGICAL

Interventions

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Gammaplex® (Human Normal Immunoglobulin)

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Female volunteers of childbearing potential had a negative pregnancy test before entering the study and had to use either a double barrier method of contraception or use the oral contraceptive pill.
* Postmenopausal or surgically sterile female volunteers could be enrolled.