BioequivalancePhase 1NCT04155814

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

A Phase 1 study testing Iron Sucrose Injection and Venofer Injection in people with Bioequivalance, run by Baxter Healthcare Corporation at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Bioequivalance
What is being tested?: Iron Sucrose Injection and Venofer Injection
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 196 participants
Where: 1 siteUnited States
Study dates: 19 Sep 2019to 18 Dec 2019
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

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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

Who cannot join

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

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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

Trial locations and contacts

1 site in 1 country.

United States1 site

Baxter Investigational Site
Miami, Florida, 33126

Other trials in United States

About this study

Official title: Bioequivalence Study Assessing a Single Dose of Iron Sucrose Injection (Baxter) or a Single Dose of Venofer® Injection in Healthy Adult Subjects

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: Bioequivalance
Being tested: Iron Sucrose Injection, Venofer Injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Iron Sucrose InjectionDrug
USP 100 mg/5 mL (20 mg/mL), solution for IV injection, 100 mg unit dose strength
Venofer InjectionDrug
(Iron Sucrose 20 mg/mL), solution for IV injection, 100 mg unit dose strength

Study groups in NCT04155814
Study group	Role	What they receive
Iron Sucrose Injection	Experimental	IV injection (5 mL), delivered over 5 minutes to subjects that have been fasted for a minimum of 10 hours. Receives: Drug: Iron Sucrose Injection
Venofer Injection	Active comparator	IV injection (5 mL), delivered over 5 minutes to subjects that have been fasted for a minimum of 10 hours. Receives: Drug: Venofer Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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 (13)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day -28 (Screening) through Day 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Sep 201918 Dec 2019

First posted7 Nov 2019
Study start19 Sep 2019
Primary completion18 Dec 2019
Study completion18 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for BioequivalanceStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 196 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04155814
Sponsor's protocol ID: BXU537298
Other IDs: QSC202208
Status last verified: Jul 2020
First submitted: 5 Nov 2019
Last updated: 31 Jul 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Bioequivalence Study Assessing a Single Dose of Iron Sucrose Injection (Baxter) or a Single Dose of Venofer® Injection in Healthy Adult Subjects
ClinicalTrials.gov ID: NCT04155814
Acronym / sponsor ID: BXU537298
Conditions: Bioequivalance
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 196 participants (actual)
Lead sponsor: Baxter Healthcare CorporationIndustry (pharma, biotech, devices)
Collaborators: Quotient Sciences
Study start: 19 Sep 2019 (actual)
Primary completion: 18 Dec 2019 (actual)
Study completion: 18 Dec 2019 (actual)
First posted: 7 Nov 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

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

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (13 listed)

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

Key exclusion criteria (26 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Iron Sucrose InjectionUSP 100 mg/5 mL (20 mg/mL), solution for IV injection, 100 mg unit dose strength	Drug	Iron Sucrose Injection
Venofer Injection(Iron Sucrose 20 mg/mL), solution for IV injection, 100 mg unit dose strength	Drug	Venofer Injection

Primary outcome

Cmax(delta)
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)
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.
AUC0-t(delta)
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)
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.

13 secondary outcomes

Cmax
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
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
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 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
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
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
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
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
Time frame: Day -28 (Screening) through Day 10 (Follow-up)
Number of participants with clinically significant findings on physical examinations
Time frame: Day -28 (Screening) through Day 10 (Follow-up)
Number of participants with clinically significant changes to ECG parameters
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)
Time frame: Day -28 (Screening) through Day 30
Number of participants with occurrence of adverse events of special interest
Time frame: Day -28 (Screening) through Day 30

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2020.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Iron Sucrose Injection and Venofer Injection in people with Bioequivalance, run by Baxter Healthcare Corporation at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax(delta) (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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04155814.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2020.