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Iron Sucrose

Phase 1

Healthy Volunteers | Small molecule | Other |Pfizer, Inc.|Last Updated: Mar 21, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment60
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00719459Bioequivalency Study Comparing Hospira's Generic Iron Sucrose Injection to VenoferPHASE1 COMPLETED 60 — — Jun 1, 2008Jul 13, 2008Mar 21, 20171 United States
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Study Endpoints
Primary Endpoints
Bioequivalence - Assessed by constructing the 90% confidence interval (CI) for the geometric mean test/reference ratios of Cmax for both baseline-adjusted total iron and baseline-adjusted transferrin-bound iron
Pharmacokinetic sampling at pre-dose (15, 10 and 5 minutes) and Post-dose 5, 10, 20, 30, 45 minutes, and 1.0,2.0,3.0,4.0,6.0,8.0, 12.0, 14.0, and 24.0 hours.

Test: Hospira Iron Sucrose Injection; Reference: Venofer Injection

Bioequivalence - Assessed by constructing the 90% CI for the geometric mean test/reference ratios of AUC0-t for both baseline-adjusted total iron and baseline-adjusted transferrin-bound iron
Pharmacokinetic sampling at pre-dose (15, 10 and 5 minutes) and Post-dose 5, 10, 20, 30, 45 minutes, and 1.0,2.0,3.0,4.0,6.0,8.0, 12.0, 14.0, and 24.0 hours.

Test: Hospira Iron Sucrose Injection; Reference: Venofer Injection

Secondary Endpoints
Time of maximum concentration (Tmax) for baseline-adjusted total iron and baseline-adjusted transferrin-bound iron
Pharmacokinetic sampling at pre-dose (15, 10 and 5 minutes) and Post-dose 5, 10, 20, 30, 45 minutes, and 1.0,2.0,3.0,4.0,6.0,8.0, 12.0, 14.0, and 24.0 hours.
Half life (t1/2) for baseline-adjusted total iron and baseline-adjusted transferrin-bound iron
Pharmacokinetic sampling at pre-dose (15, 10 and 5 minutes) and Post-dose 5, 10, 20, 30, 45 minutes, and 1.0,2.0,3.0,4.0,6.0,8.0, 12.0, 14.0, and 24.0 hours.
Elimination rate constant (λz) for baseline-adjusted total iron and baseline-adjusted transferrin-bound iron
Pharmacokinetic sampling at pre-dose (15, 10 and 5 minutes) and Post-dose 5, 10, 20, 30, 45 minutes, and 1.0,2.0,3.0,4.0,6.0,8.0, 12.0, 14.0, and 24.0 hours.
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALHospira Iron Sucrose
2ACTIVE_COMPARATORVenofer
Interventions
NameTypeDescription
Iron SucroseDRUGVenofer 20 mg/mL
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Healthy male and female volunteers between 18 and 55 years of age (both inclusive). 2. Having a Body Mass Index (BMI) between 18.5 and 32.0 kg/m2 (both inclusive). 3. If female, subject must be either postmenopausal for at least 1 year, surgically sterile (bilateral tubal lig...

Countries:United States
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