Healthy VolunteersPhase 1NCT00719459
Bioequivalency Study Comparing Hospira's Generic Iron Sucrose Injection to Venofer
A Phase 1 study testing Iron Sucrose in people with Healthy Volunteers, run by Hospira, now a wholly owned subsidiary of Pfizer at 1 site in United States.
Trial summary
The primary objective of this study is to assess the bioequivalence of the test product Hospira Iron Sucrose 20 mg/mL (Hospira, Inc.) to the reference product Venofer® 20 mg/mL following intravenous administration to 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
- Healthy Volunteers
- What is being tested?
- Iron Sucrose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to 13 Jul 2008
- 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 male and female volunteers between 18 and 55 years of age (both inclusive).
- Having a Body Mass Index (BMI) between 18.5 and 32.0 kg/m2 (both inclusive).
- If female, subject must be either postmenopausal for at least 1 year, surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or practicing birth control:
- hormonal contraceptives (oral, parenteral or transdermal) for at least 3 months prior to study drug administration
- intrauterine device (IUD)
- double-barrier method (condoms, contraceptive sponge, diaphragm or vaginal ring with spermicidal jellies or cream).
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- If hormonal contraceptives are used, the specific contraceptive must have been used for at least 3 months prior to study drug administration. If the subject is currently using a hormonal contraceptive, she should also use a barrier method during this study and for 1 month after study completion.
- Must have, in the investigator's opinion, no abnormal laboratory evaluations taken at Screening visit or admission to the Phase 1 unit on Day -1.
- Must be a non-smoker (defined as a subject who has not smoked for 3 months) and agree to abstain from alcohol for 24 hours prior to each dosing treatment and while a resident in the treatment unit.
- Able to provide written informed consent after risks and benefits of the study have been explained.
- Able to communicate effectively with study personnel.
Who cannot join
- Documented bleeding disorders, acute bleeding or recently documented hemorrhage.
- Any disease or condition that might interfere with the absorption, distribution, metabolism, or excretion of the study drug or would place the subject at increased risk.
- History of drug abuse or alcohol abuse within 2 years of study enrollment as determined by the investigator or a positive urine drug test prior to Day -1.
- Use of any prescription medicine within 14 days prior to start of the study, or over the counter medications or herbal remedies within 3 days prior to study entry (vitamins or calcium supplements allowed, except iron supplements).
- Use of iron supplements within 3 months of the start of the study.
- A subject with anemia (hemoglobin < 8 mg/dL).
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- Relative or absolute iron deficiency or iron overload.
- Clinically significant medical or psychiatric illness currently or within 30 days of study entry as determined by investigator.
- Significant drug sensitivity or a significant allergic reaction to any drug.
- Known hypersensitivity or idiosyncratic reaction to iron sucrose injection or any other related drugs.
- A positive result at screening for HIV, Hepatitis B or C.
- A subject who has been administered an injectable drug within 14 days prior to the start of the study.
- A subject who has donated or lost 475 mL (i.e., 1 pint) or more blood volume (including plasmaphoresis) or had a transfusion of any blood product within 3 months prior to the initial study drug administration.
- Current participation or participation within 30 days prior to the initial study drug administration in a drug or other investigational research study.
- A subject who may not be able to comply with the safety monitoring requirements of this clinical trial or is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Bio-Kinetic Clinical Applications
Springfield, Missouri, 65802
About this study
Official title: A Randomized, Open-Label, Single-Dose, Parallel-Design, Bioequivalence Study of Hospira Iron Sucrose Injection Compared to Venofer® Injection USP in Healthy Subjects.
The primary objective of this study is to assess the bioequivalence of the test product Hospira Iron Sucrose 20 mg/mL (Hospira, Inc.) to the reference product Venofer® 20 mg/mL following intravenous administration to healthy subjects.
Read the detailed description
Iron is essential to the synthesis of hemoglobin (Hb) to maintain oxygen transport and to the function and formation of other physiologically important heme and nonheme compounds. Iron deficiency may be caused by blood loss during dialysis, increased erythropoiesis following administration of epoetin, and insufficient absorption of iron from the gastro-intestinal tract. Most dialysis patients require intravenous iron supplementation to replenish iron stores.
Iron sucrose is used to replenish body iron stores in patients with iron deficiency on chronic hemodialysis and receiving erythropoietin. In these patients iron deficiency is caused by blood loss during dialysis procedure, increased erythropoiesis, and insufficient absorption of iron from the gastrointestinal tract. Most hemodialysis patients require intravenous iron to maintain sufficient iron stores to achieve and maintain a hemoglobin level of 11-12 g/dL.
Subjects who fulfill the inclusion/exclusion criteria after screening will be randomized to receive 100 mg of iron sucrose as either Hospira Iron Sucrose or Venofer®.
- Conditions
- Healthy Volunteers
- Being tested
- Iron Sucrose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron SucroseDrug
Venofer 20 mg/mL
Iron SucroseDrug
Iron sucrose 20 mg/mL
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Hospira Iron Sucrose Receives: Drug: Iron Sucrose |
| 2 | Active comparator | Venofer Receives: Drug: Iron Sucrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Test: Hospira Iron Sucrose Injection; Reference: Venofer Injection
Measured: 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.
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
Test: Hospira Iron Sucrose Injection; Reference: Venofer Injection
Measured: 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.
Secondary outcomes (3)
Time of maximum concentration (Tmax) for baseline-adjusted total iron and baseline-adjusted transferrin-bound iron
Measured: 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
Measured: 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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2008 (estimated)
- Study startJun 2008
- Primary completionJul 2008
- Study completion13 Jul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00719459
- Sponsor's protocol ID
- IRON-07-04
- Status last verified
- Jun 2015
- First submitted
- 15 Jul 2008
- Last updated
- 21 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Single-Dose, Parallel-Design, Bioequivalence Study of Hospira Iron Sucrose Injection Compared to Venofer® Injection USP in Healthy Subjects.
- ClinicalTrials.gov ID
- NCT00719459
- Acronym / sponsor ID
- IRON-07-04
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hospira, now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Jul 2008 (actual)
- Study completion
- 13 Jul 2008 (actual)
- First posted
- 21 Jul 2008 (estimated)
- 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.
The primary objective of this study is to assess the bioequivalence of the test product Hospira Iron Sucrose 20 mg/mL (Hospira, Inc.) to the reference product Venofer® 20 mg/mL following intravenous administration to healthy subjects.
Detailed description
Iron is essential to the synthesis of hemoglobin (Hb) to maintain oxygen transport and to the function and formation of other physiologically important heme and nonheme compounds. Iron deficiency may be caused by blood loss during dialysis, increased erythropoiesis following administration of epoetin, and insufficient absorption of iron from the gastro-intestinal tract. Most dialysis patients require intravenous iron supplementation to replenish iron stores.
Iron sucrose is used to replenish body iron stores in patients with iron deficiency on chronic hemodialysis and receiving erythropoietin. In these patients iron deficiency is caused by blood loss during dialysis procedure, increased erythropoiesis, and insufficient absorption of iron from the gastrointestinal tract. Most hemodialysis patients require intravenous iron to maintain sufficient iron stores to achieve and maintain a hemoglobin level of 11-12 g/dL.
Subjects who fulfill the inclusion/exclusion criteria after screening will be randomized to receive 100 mg of iron sucrose as either Hospira Iron Sucrose or Venofer®.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Iron SucroseHospira Iron Sucrose |
| 2 | Active comparator | Drug: Iron SucroseVenofer |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Healthy male and female volunteers between 18 and 55 years of age (both inclusive).
- Having a Body Mass Index (BMI) between 18.5 and 32.0 kg/m2 (both inclusive).
- If female, subject must be either postmenopausal for at least 1 year, surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or practicing birth control:
- If hormonal contraceptives are used, the specific contraceptive must have been used for at least 3 months prior to study drug administration. If the subject is currently using a hormonal contraceptive, she should also use a barrier method during this study and for 1 month after study completion.
- Must have, in the investigator's opinion, no abnormal laboratory evaluations taken at Screening visit or admission to the Phase 1 unit on Day -1.
Key exclusion criteria (15 listed)
- Documented bleeding disorders, acute bleeding or recently documented hemorrhage.
- Any disease or condition that might interfere with the absorption, distribution, metabolism, or excretion of the study drug or would place the subject at increased risk.
- History of drug abuse or alcohol abuse within 2 years of study enrollment as determined by the investigator or a positive urine drug test prior to Day -1.
- Use of any prescription medicine within 14 days prior to start of the study, or over the counter medications or herbal remedies within 3 days prior to study entry (vitamins or calcium supplements allowed, except iron supplements).
- Use of iron supplements within 3 months of the start of the study.
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 SucroseVenofer 20 mg/mL | Drug | 2 |
| Iron SucroseIron sucrose 20 mg/mL | Drug | 1 |
Primary outcome
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
Time frame: 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
Time frame: 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
3 secondary outcomes
Time of maximum concentration (Tmax) for baseline-adjusted total iron and baseline-adjusted transferrin-bound iron
Time frame: 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
Time frame: 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
Time frame: 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.
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 21 Mar 2017.
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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 in people with Healthy Volunteers, run by Hospira, now a wholly owned subsidiary of Pfizer 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 11 inclusion and 15 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 21 Mar 2017. 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?
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 (time frame: 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.). 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?
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 21 Mar 2017.