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

NCT02246842 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2018-03-14

No results posted yet for this study

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

  • Healthy

Interventions

BIOLOGICAL

D-Gam® (human anti-D immunoglobulin)

BIOLOGICAL

Rhophylac® (human anti-D immunoglobulin)

Sponsors & Collaborators

  • Bio Products Laboratory

    lead OTHER

Principal Investigators

  • Dr A Sutton, MB BS, FFARCSI · Guildford Clinical Pharmacology Unit

Study Design

Purpose
TREATMENT

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-05-31
Primary Completion
2004-12-31

Countries

  • United Kingdom

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02246842 on ClinicalTrials.gov