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

Information source: Bio Products Laboratory
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: D-Gam® (human anti-D immunoglobulin) (Biological); Rhophylac® (human anti-D immunoglobulin) (Biological)

Phase: Phase 1

Status: Completed

Sponsored by: Bio Products Laboratory

Official(s) and/or principal investigator(s):
Dr A Sutton, MB BS, FFARCSI, Principal Investigator, Affiliation: Guildford Clinical Pharmacology Unit

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.

Clinical Details

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

Study design: Endpoint Classification: Pharmacokinetics Study, Primary Purpose: Treatment

Primary outcome: Cmax for anti-D

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Female.

Criteria:

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.

Locations and Contacts

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

Sponsor's Homepage

Starting date: May 2004
Last updated: September 19, 2014

Page last updated: August 23, 2015

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