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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02246842

Enrollment

Unknown

Registered

2014-09-23

Start date

2004-05-31

Completion date

Unknown

Last updated

2018-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Volunteers

Brief 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.

Interventions

BIOLOGICALD-Gam® (human anti-D immunoglobulin)

BIOLOGICALRhophylac® (human anti-D immunoglobulin)

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026