Status:
COMPLETED
A Comparison of the Pharmacokinetics, Safety and Tolerance of Two Formulations of a Liquid IVIg in Healthy Volunteers
Lead Sponsor:
Bio Products Laboratory
Conditions:
Healthy
Eligibility:
All Genders
Phase:
PHASE1
Brief 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 ...
Eligibility Criteria
Inclusion
- Healthy, normotensive, non-smoking male and female volunteers aged 18 to 60 who gave written informed consent and fulfilled all of the inclusion criteria and none of the exclusion 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.
Exclusion
- \-
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02246855
Start Date
August 1 2004
Last Update
February 27 2018
Active Locations (1)
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1
Clinical Pharmacology Research Unit (CPRU)
Level 7, Northwick Park Hospital, Watford Road, Harrow, United Kingdom, HA1 3UJ