CompletedNCT04155814Updated Jul 31, 2020

Bioequivalence Study Assessing Iron Sucrose or Venofer® in Healthy Adult Subjects

A Phase 1 interventional study of Iron Sucrose Injection and Venofer Injection in Bioequivalance, sponsored by Baxter Healthcare Corporation. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-31.

Sponsored by Baxter Healthcare Corporation · Phase 1, Interventional, and Treatment

From the registry’s dates

Primary completion was Dec 2019, 6 years 9 months ago, and no results have been posted to the registry.

Phase: Phase 1
Study type: Interventional
Enrollment: 196
Allocation: Randomized
Ages: 18 Years to 55 Years
Sex: All

Study summary

This study evaluates the bioequivalence, pharmacokinetic (PK) profile, and safety and tolerability of Iron Sucrose (Test Product) relative to that of Venofer® in healthy subjects.

Conditions studied

Bioequivalance

In context

Lead sponsor

Baxter Healthcare Corporation is the lead sponsor of 78 studies on the registry; 1 is open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 3 (30%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Healthy males or non-pregnant, non-lactating healthy females
Age 18 to 55 years of age (both inclusive)
Must, in the opinion of the investigator, be in good health based upon medical history, physical examination (including vital signs and ECGs) and clinical laboratory tests assessed at the time of screening
Body mass index (BMI) of 18.0 to 32.0 kg/m2 and a minimum body weight of 40 kg, or if outside the range, considered not clinically significant by the investigator
Ferritin levels not less than the lower limit of normal as defined by clinical laboratory reference ranges for female and male subjects at screening only
Transferrin Saturation (TSAT) not less than the lower limit of normal as defined by clinical laboratory reference ranges for female and male subjects at screening only
Hemoglobin levels not less than the lower limit of normal as defined by clinical laboratory reference ranges for male and female subjects
Must agree to use an adequate method of contraception:
- For male subjects: Subjects willing to follow approved birth control methods (a double barrier method) for the duration of the study as judged by the investigator(s), such as condom with spermicide, condom with diaphragm, or abstinence. Subjects should also not donate sperm during this time.
- For female subjects: Female subjects of childbearing potential, defined as a woman \< 55 years of age who has not had a partial or full hysterectomy or oophorectomy, must have a negative urine pregnancy test at screening and a negative beta human chorionic gonadotropin (β-hCG) pregnancy test at admission. Subjects of childbearing potential must use a medically acceptable means of contraception during their participation in the study
Non-smoker, defined as: Non-smoker for > 12 months (i.e., subject has not smoked or used any tobacco product, e-cigarettes, and nicotine replacement products for the 12 months prior to the start of the study) based on subject report.
Must be willing and able to comply with all study requirements
Must be able to understand a written informed consent, which must be obtained prior to initiation of study procedures

Exclusion criteria

Exclusion Criteria:

Hypersensitivity to iron sucrose or iron products
Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active
Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
Clinically significant abnormal biochemistry, hematology or urinalysis as judged by the investigator
History of iron deficiency within 6 months prior to screening
History of anemia within 6 months prior to screening
Suspicion of iron overload as evidenced by both elevated serum TSAT and serum ferritin levels
History of hemochromatosis
Bleeding disorders, acute bleeding or recently documented hemorrhage
Females with history of hypermenorrhea or menorrhagia
History of cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder, as judged by the investigator
Must not have significant serious skin disease, including rash, food allergy, eczema, psoriasis, or urticaria
Female subjects who are currently pregnant, lactating, or planning to become pregnant during the study period
Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
Positive drugs of abuse test result or history of drug abuse in the past 6 months based on subject report
Positive urinalysis test for alcohol at screening or history of alcoholism in the past 6 months based on subject report
Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 Units = 125 mL glass of wine, depending on type)
Administration of an injectable drug within 14 days prior to drug administration in this study
Subjects who are taking, or have taken, any prescribed or over-the-counter drug (other than up to 4 g per day acetaminophen in the 14 days before IMP administration, hormonal contraceptives, or hormone replacement therapy. Exceptions may apply on a case by case basis, if considered not to interfere with the objectives of the study, as agreed by the PI and sponsor's medical monitor
Use of iron supplements (including iron-containing multivitamins) within 3 months of the first dose IMP administration in the study
Have poor venous access that limits phlebotomy
Subjects who have donated blood (1 unit = 450 mL) within 3 months prior to the first dose of the study drug and plasma within 7 days prior to the first dose of the study drug.
Subjects who have received any IMP in a clinical research study within 5 half-lives or within 30 days prior to first dose. However, in no event, shall the time between last receipt of IMP and first dose be less than 30 days
Subjects who are study site employees, or immediate family members of a study site or sponsor employee
Subjects who have previously been enrolled in this study
Failure to satisfy the investigator of fitness to participate for any other reason

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 196 participants (actual)

Study arms

Experimental
Iron Sucrose Injection
IV injection (5 mL), delivered over 5 minutes to subjects that have been fasted for a minimum of 10 hours.
Drug: Iron Sucrose Injection
Active comparator
Venofer Injection
IV injection (5 mL), delivered over 5 minutes to subjects that have been fasted for a minimum of 10 hours.
Drug: Venofer Injection

Interventions

DrugIron Sucrose Injection
USP 100 mg/5 mL (20 mg/mL), solution for IV injection, 100 mg unit dose strength
DrugVenofer Injection
(Iron Sucrose 20 mg/mL), solution for IV injection, 100 mg unit dose strength

What researchers measure

Primary outcomes

Cmax(delta)
Maximum concentration (Cmax) across all time points for the delta difference between Total Iron (TI) and Transferrin Bound Iron (TBI). This is a PK test parameter to compare bioequivalence of two drug products.
Time frame: Hours before injection (24, 12, 0.25); Minutes after end of injection (1, 5, 10, 15, 30, 45); Hours after end of injection (1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 36)
AUC0-t(delta)
Area under the concentration curve (AUC) from time zero to last time of quantifiable concentration (Tlast) for the delta difference in AUC0-t between TI and TBI. This is a PK test parameter to compare bioequivalence of two plasma drug products.
Time frame: Hours before injection (24, 12, 0.25); Minutes after end of injection (1, 5, 10, 15, 30, 45); Hours after end of injection (1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 36)

Secondary outcomes

Cmax
Maximum concentration (Cmax) across all time points for both TI and TBI. This is a PK test parameter to compare bioequivalence of two plasma drug products.
Time frame: Hours before injection (24, 12, 0.25); Minutes after end of injection (1, 5, 10, 15, 30, 45); Hours after end of injection (1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 36)
AUC0-t
Area under the concentration-time curve (AUC) from time zero to last sample time for both TI and TBI. This is a PK test parameter to compare bioequivalence of two drug products.
Time frame: Hours before injection (24, 12, 0.25); Minutes after end of injection (1, 5, 10, 15, 30, 45); Hours after end of injection (1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 36)
AUC0-inf
Area under the concentration-time curve (AUC) from time zero extrapolated to infinity for both TI and TBI. This is a PK test parameter to compare bioequivalence of two drug products.
Time frame: Hours before injection (24, 12, 0.25); Minutes after end of injection (1, 5, 10, 15, 30, 45); Hours after end of injection (1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 36)
Tmax
Time of occurrence of Cmax (Tmax) for both TI and TBI. This is a PK test parameter to compare bioequivalence of two drug products.
Time frame: Hours before injection (24, 12, 0.25); Minutes after end of injection (1, 5, 10, 15, 30, 45); Hours after end of injection (1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 36)
t1/2
Terminal phase half-life (t1/2) for both TI and TBI. This is a PK test parameter to compare bioequivalence of two drug products.
Time frame: Hours before injection (24, 12, 0.25); Minutes after end of injection (1, 5, 10, 15, 30, 45); Hours after end of injection (1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 36)
Vz
Volume of distribution (Vz) for both TI and TBI. This is a PK test parameter to compare bioequivalence of two drug products.
Time frame: Hours before injection (24, 12, 0.25); Minutes after end of injection (1, 5, 10, 15, 30, 45); Hours after end of injection (1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 36)
CL
Total body clearance (CL) for extravascular administration calculated by Dose/AUC for both TI and TBI. This is a PK test parameter to compare bioequivalence of two drug products.
Time frame: Hours before injection (24, 12, 0.25); Minutes after end of injection (1, 5, 10, 15, 30, 45); Hours after end of injection (1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 36)
Percentage of AUCex
AUC0-inf due to extrapolation (AUCex) from Tlast to infinity calculated by: 100 × (AUC0-inf-AUC0-t)/AUC0-inf (%AUCex) for both TI and TBI. This is a PK test parameter to compare bioequivalence of two drug products.
Time frame: Hours before injection (24, 12, 0.25); Minutes after end of injection (1, 5, 10, 15, 30, 45); Hours after end of injection (1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 36)
Number of participants with clinically significant laboratory abnormalities
Any clinically significant abnormality will also be reported as an AE.
Time frame: Day -28 (Screening) through Day 10 (Follow-up)
Number of participants with clinically significant findings on physical examinations
Any clinically significant abnormality will also be reported as an AE.
Time frame: Day -28 (Screening) through Day 10 (Follow-up)
Number of participants with clinically significant changes to ECG parameters
Any clinically significant abnormality will also be reported as an AE.
Time frame: Day -28 (Screening), Day -2, 0.25 hours before injection, and 6, 24 and 36 hours after end of injection
Number of participants with occurrence of adverse events (AEs)
An AE is any untoward medical occurrence in a subject that occurs either before dosing (referred to as a pre-dose AE) or once a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product.
Time frame: Day -28 (Screening) through Day 30
Number of participants with occurrence of adverse events of special interest
Special interest items includes hypersensitivity reactions including anaphylactic/anaphylactoid reactions.
Time frame: Day -28 (Screening) through Day 30

Study locations

1 site

Baxter Investigational Site
Miami, Florida 33126, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 31, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04155814
Lead sponsor: Baxter Healthcare Corporation
Collaborators: Quotient Sciences
Responsible party: Sponsor
First posted: Nov 7, 2019
Start date: Sep 19, 2019
Primary completion: Dec 18, 2019
Completion: Dec 18, 2019
Last update: Jul 31, 2020

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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