drugset / Trial / NCT02246842

A Study Comparing the Pharmacokinetics and Tolerance of D-Gam® to Rhophylac® in Rh-D-negative Healthy Volunteers.

NCT02246842 ↗

Phase 1 Completed Bio Products Laboratory
Treatment

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.

Timeline

Start
2004-05
Primary completion
2004-12
Completion
—

Drugs

EvaluationDrugModalityDoseRoute
Subject D-Gam® Protein / enzyme biologic 1500 iu —
Comparator Rhophylac® Protein / enzyme biologic 1500 iu —

Indications

No indication recorded.