Bioequivalency Study Comparing Hospira's Generic Iron Sucrose Injection to Venofer

• Status: Completed
• Trial end date: 2008-07-13
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hospira, Inc.; Hospira, now a wholly owned subsidiary of Pfizer
• Treatments: Ferric Compounds; Ferric Oxide, Saccharated; Iron

Criteria

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 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).

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.

4. 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.

5. 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.

6. Able to provide written informed consent after risks and benefits of the study have been explained.

7. Able to communicate effectively with study personnel.

Exclusion Criteria:

1. Documented bleeding disorders, acute bleeding or recently documented hemorrhage.

2. 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.

3. 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.

4. 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).

5. Use of iron supplements within 3 months of the start of the study.

6. A subject with anemia (hemoglobin < 8 mg/dL).

7. Relative or absolute iron deficiency or iron overload.

8. Clinically significant medical or psychiatric illness currently or within 30 days of study entry as determined by investigator.

9. Significant drug sensitivity or a significant allergic reaction to any drug.

10. Known hypersensitivity or idiosyncratic reaction to iron sucrose injection or any other related drugs.

11. A positive result at screening for HIV, Hepatitis B or C.

12. A subject who has been administered an injectable drug within 14 days prior to the start of the study.

13. 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.

14. Current participation or participation within 30 days prior to the initial study drug administration in a drug or other investigational research study.

15. 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.