Status:
COMPLETED
A Study Comparing the Pharmacokinetics and Tolerance of D-Gam® to Rhophylac® in Rh-D-negative Healthy Volunteers.
Lead Sponsor:
Bio Products Laboratory
Conditions:
Healthy
Eligibility:
FEMALE
Phase:
PHASE1
Brief Summary
The primary objective of the study was to compare peak serum anti-D levels (Cmax) of BPL's D-Gam® 1500 IU to Rhophylac® 1500IU in RhD-negative healthy volunteers.
Eligibility Criteria
Inclusion
- Females
- Ages of 18 and 55 years
- Bodyweight of 50-85kg.
Exclusion
- Clinically relevant abnormalities at physical examination, ECG or laboratory tests.
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02246842
Start Date
May 1 2004
Last Update
March 14 2018
Active Locations (1)
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1
Guildford Clinical Pharmacology Unit
Unit 34, Surrey Technology Centre, Surrey Research Park, Occam Road, Guildford, Surrey, United Kingdom, GU2 7YG