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A Study Comparing The Effects Of Epoetin Hospira Single-Dose Vial (SDV) And Multi-Dose Vial (MDV) When Administered Subcutaneously To Normal Healthy Subjects

NCT03398473 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2018-05-17

No results posted yet for this study

Summary

This study will assess the PK similarity of epoetin administered as Hospira MDV versus Hospira SDV by conducting a single-dose comparative evaluation in normal healthy subjects enrolled at a single center.

Conditions

  • Healthy

Interventions

DRUG

Epoetin Hospira SDV

Epoetin Hospira Single Dose Vial

DRUG

Epoetin Hospira MDV

Epoetin Hospira Multi-Dose Vial

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-25
Primary Completion
2018-04-11
Completion
2018-05-07
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT03398473 on ClinicalTrials.gov