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Iron Sucrose

Phase 1

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

Success Probability

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

Iron Sucrose · 1 trial · 1 indication

Phase 1 1
NCT00719459Bioequivalency Study Comparing Hospira's Generic Iron Sucrose Injection to VenoferHealthy Volunteers
COMPLETED60 Analytics
PHASE1COMPLETED
Bioequivalency Study Comparing Hospira's Generic Iron Sucrose Injection to Venofer
Healthy Volunteers
NCT0071945960
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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 to 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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Frequently asked questions about Iron Sucrose

What is Iron Sucrose used for?

Iron Sucrose is used for treating iron deficiency in healthy volunteers, as studied in a Phase 1 clinical trial. It is an investigational small molecule being developed by Pfizer, Inc. for this purpose. The drug is administered to healthy volunteers to assess its effects and bioequivalence.

What does Iron Sucrose target?

Iron Sucrose targets iron deficiency by providing a source of iron to the body. It is a small molecule that delivers iron, which is essential for red blood cell production and oxygen transport. The drug is designed to replenish iron stores in individuals with iron deficiency.

Who makes Iron Sucrose?

Iron Sucrose is being developed by Pfizer, Inc., a biopharmaceutical company. Pfizer is conducting clinical trials to evaluate the drug's safety and efficacy. The company is responsible for the research and development of Iron Sucrose as an investigational treatment for iron deficiency.

What phase is Iron Sucrose in?

Iron Sucrose is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 1 trial is focused on assessing the drug's safety, tolerability, and pharmacokinetics in healthy volunteers.

What clinical trials is Iron Sucrose in?

Iron Sucrose is being studied in a Phase 1 clinical trial with the identifier NCT00719459. This trial is a bioequivalency study comparing Hospira's generic Iron Sucrose Injection to Venofer. The study has been completed and enrolled 60 healthy volunteers in the United States.

Is Iron Sucrose the same as Venofer?

Iron Sucrose is being studied as a generic version of Venofer. The clinical trial NCT00719459 is designed to compare the bioequivalence of Hospira's generic Iron Sucrose Injection to Venofer. This means Iron Sucrose is intended to be therapeutically equivalent to Venofer, though it is still under investigation.