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

NCT ID: NCT02246842

Last Updated: 2018-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Primary Study Purpose

TREATMENT

Study Groups

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D-Gam®

D-Gam® (human anti-D immunoglobulin)

Group Type EXPERIMENTAL

D-Gam® (human anti-D immunoglobulin)

Intervention Type BIOLOGICAL

Rhophylac®

Human Anti-D Immunoglobulin

Group Type ACTIVE_COMPARATOR

Rhophylac® (human anti-D immunoglobulin)

Intervention Type BIOLOGICAL

Interventions

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D-Gam® (human anti-D immunoglobulin)

Intervention Type BIOLOGICAL

Rhophylac® (human anti-D immunoglobulin)

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Bio Products Laboratory

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr A Sutton, MB BS, FFARCSI

Role: PRINCIPAL_INVESTIGATOR

Guildford Clinical Pharmacology Unit

Locations

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Guildford Clinical Pharmacology Unit

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

Site Status

Countries

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United Kingdom

Related Links

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http://www.bpl.co.uk

Sponsor's Homepage

Other Identifiers

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POLYAD04

Identifier Type: -

Identifier Source: org_study_id

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