Trials / Completed
CompletedNCT02246842
A Study Comparing the Pharmacokinetics and Tolerance of D-Gam® to Rhophylac® in Rh-D-negative Healthy Volunteers.
A Randomised Study Comparing the Pharmacokinetics and Tolerance of D-Gam® 1500IU to Rhophylac® 1500IUin Rh-D-negative Healthy Volunteers.
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Bio Products Laboratory · Academic / Other
- Sex
- Female
- Age
- —
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | D-Gam® (human anti-D immunoglobulin) | |
| BIOLOGICAL | Rhophylac® (human anti-D immunoglobulin) |
Timeline
- Start date
- 2004-05-01
- Primary completion
- 2004-12-01
- First posted
- 2014-09-23
- Last updated
- 2018-03-14
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT02246842. Inclusion in this directory is not an endorsement.