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

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.

Completed

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Key information

Conditions

Healthy

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Guildford Clinical Pharmacology Unit

Unit 34, Surrey Technology Centre, Surrey Research Park, Occam Road, Guildford, Surrey, GU2 7YG, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

D-Gam® (human anti-D immunoglobulin)

Biological

Rhophylac® (human anti-D immunoglobulin)

Biological

Primary outcomes

Cmax for anti-D

Time frame: Pre-dose, 1, 8, 24, 32, 48, 72 & 96 hours; 1, 2, 3, 4, 5, 6, 8, 10, 12 & 14 weeks post-dose

Sponsors and collaborators

Lead sponsor

Bio Products Laboratory

Other

Registry information

Official study title

A Randomised Study Comparing the Pharmacokinetics and Tolerance of D-Gam® 1500IU to Rhophylac® 1500IUin Rh-D-negative Healthy Volunteers.

Important dates

Study start: 2004
Primary completion: 2004
First posted: Sep 23, 2014
Registry last updated: Mar 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed