Healthy Clinical Trial
Official title:
A Randomised Study Comparing the Pharmacokinetics and Tolerance of D-Gam® 1500IU to Rhophylac® 1500IUin Rh-D-negative Healthy Volunteers.
| NCT number | NCT02246842 |
| Other study ID # | POLYAD04 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 1 |
| First received | September 15, 2014 |
| Last updated | March 12, 2018 |
| Start date | May 2004 |
| Verified date | March 2018 |
| Source | Bio Products Laboratory |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | December 2004 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - Females - Ages of 18 and 55 years - Bodyweight of 50-85kg. Exclusion Criteria: - Clinically relevant abnormalities at physical examination, ECG or laboratory tests. |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Guildford Clinical Pharmacology Unit | Unit 34, Surrey Technology Centre, Surrey Research Park | Occam Road, Guildford, Surrey |
| Lead Sponsor | Collaborator |
|---|---|
| Bio Products Laboratory |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Cmax for anti-D | Pre-dose, 1, 8, 24, 32, 48, 72 & 96 hours; 1, 2, 3, 4, 5, 6, 8, 10, 12 & 14 weeks post-dose |
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