Trials / Completed
CompletedNCT02246855
A Comparison of the Pharmacokinetics, Safety and Tolerance of Two Formulations of a Liquid IVIg in Healthy Volunteers
A Comparison of the Pharmacokinetics, Safety and Tolerance of Two Formulations of a Liquid IVIg (Vigam® Liquid and Gammaplex®) Using Standard and Accelerated Infusion Rates in Healthy Adult Volunteers (Three Treatment Arms)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Bio Products Laboratory · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Gammaplex® (Human Normal Immunoglobulin) |
Timeline
- Start date
- 2004-08-01
- Primary completion
- 2004-12-01
- First posted
- 2014-09-23
- Last updated
- 2018-02-27
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT02246855. Inclusion in this directory is not an endorsement.