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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vigam® Liquid infused at up to 3mL/min | Experimental | Gammaplex® (Human Normal Immunoglobulin) |
|
| Gammaplex® infused at up to 3mL/min | Experimental | Gammaplex® (Human Normal Immunoglobulin) |
|
| Gammaplex® infused at up to 6mL/min | Experimental | Gammaplex® (Human Normal Immunoglobulin) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gammaplex® (Human Normal Immunoglobulin) | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters for serum immunoglobulin G (IgG) | Screening, pre-dose (Day 1), 15 min, 4 hr, 24 hr, 30 hr, 48 hr, Days 4, 8, 11, 15, 18, 22, 29, 36, 43, 50, 57, 71, 85 |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Name | Affiliation | Role |
|---|---|---|
| David Wessels, MBChB MBA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology Research Unit (CPRU) | Level 7, Northwick Park Hospital | Watford Road, Harrow | HA1 3UJ | United Kingdom |
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| ID | Term |
|---|---|
| D005719 | gamma-Globulins |
| ID | Term |
|---|---|
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
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| D000602 |
| Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |