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Epoetin Hospira SDV

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: May 17, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment68

FDA Designations

No designations recorded

Clinical trial landscape

Epoetin Hospira SDV · 1 trial · 1 indication

Phase 1 1
NCT03398473A Study Comparing The Effects Of Epoetin Hospira Single-Dose Vial (SDV) And Multi-Dose Vial (MDV) When Administered Subcutaneously To Normal Healthy SubjectsHealthy
COMPLETED68 Analytics
PHASE1COMPLETED
A Study Comparing The Effects Of Epoetin Hospira Single-Dose Vial (SDV) And Multi-Dose Vial (MDV) When Administered Subcutaneously To Normal Healthy Subjects
Healthy
NCT0339847368
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Study Endpoints

Primary Endpoints

Maximum serum concentration (C max) of PF-06946151 SDV
[Time Frame: 0, 0.5, 3, 6, 9, 12, 15, 24, 30, 36, 48, 72, 96, and 120 hours after dose administration]
Maximum serum concentration (C max) of PF-06946151 MDV
[Time Frame: 0, 0.5, 3, 6, 9, 12, 15, 24, 30, 36, 48, 72, 96, and 120 hours after dose administration]
Area under the serum PF-06946151 SDV concentration-time profile (AUC last) from time 0 to the last quantifiable concentration (C last)
[Time Frame: 0, 0.5, 3, 6, 9, 12, 15, 24, 30, 36, 48, 72, 96, and 120 hours after dose administration]
Area under the serum PF-06946151 MDV concentration-time profile (AUC last) from time 0 to the last quantifiable concentration (C last)
[Time Frame: 0, 0.5, 3, 6, 9, 12, 15, 24, 30, 36, 48, 72, 96, and 120 hours after dose administration]
Area under the PF-06946151 SDV concentration-time profile (AUC inf) from time zero extrapolated to infinity
[Time Frame: 0, 0.5, 3, 6, 9, 12, 15, 24, 30, 36, 48, 72, 96, and 120 hours after dose administration]
Area under the PF-06946151 MDV concentration-time profile (AUC inf) from time zero extrapolated to infinity
[Time Frame: 0, 0.5, 3, 6, 9, 12, 15, 24, 30, 36, 48, 72, 96, and 120 hours after dose administration]

Secondary Endpoints

Time to reach maximum concentration (T max) of PF-06946151 SDV
[Time Frame: 0, 0.5, 3, 6, 9, 12, 15, 24, 30, 36, 48, 72, 96 and 120 hours after dose administration]
Time to reach maximum concentration (T max) of PF-06946151 MDV
[Time Frame: 0, 0.5, 3, 6, 9, 12, 15, 24, 30, 36, 48, 72, 96 and 120 hours after dose administration]
Elimination half life (T 1/2) of PF-06946151 SDV
[Time Frame: 0, 0.5, 3, 6, 9, 12, 15, 24, 30, 36, 48, 72, 96 and 120 hours after dose administration]
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Epoetin Hospira SDVEXPERIMENTALEpoetin Hospira Single Dose Vial (SDV)
Epoetin Hospira MDVEXPERIMENTALEpoetin Hospira Multi-Dose Vial (MDV)

Interventions

NameTypeDescription
Epoetin Hospira SDVDRUGEpoetin Hospira Single Dose Vial
Epoetin Hospira MDVDRUGEpoetin Hospira Multi-Dose Vial
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Healthy female and male subjects who, at time of Screening, are between ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination including blood pressure and pulse rate m...

Countries:United States
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