Clinical trial: Bioequivalence Study Assessing Iron Sucrose or Venofer® in Healthy Adult Subjects (NCT04155814)

Eligibility criteria:
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:

          -  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
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 55 Years

Patient description (medical language): A 51-year-old man comes to the office complaining of fatigue and some sexual problems including lack of libido. The patient doesn't smoke or use any illicit drug.  Blood pressure is 120/80 mm Hg and pulse is 70/min.  Oxygen saturation is 99% on room air.  BMI is 24 kg/m2.  Skin examination shows increased pigmentation. Genotype testing is consistent with homozygosity for the C282Y mutation. Laboratory study shows transferrin saturation of 55% and serum ferritin of 550 μg/L. He is diagnosed as a case of hemochromatosis.

Patient description (patient's own words): I am 51 years old and I just came back from the doctor's office. I'm sick and tired of being that exhausted, reaching the point where me and my lovely wife are not touching each other anymore! I'm not smoking or doing drugs! My blood pressure was 120/80 mm Hg, and pulse was 70/min and my oxygen saturation 99%. My BMI is 24. My skin also turned a bit darker lately. He tested my genes and told me that I have a mutation of the C282Y gene. I also did lab tests where my transferrin saturation was 55% and serum ferritin was 550  μg/L. The doctor diagnosed me with iron overload.

Does the patient match the trial criteria? Contradiction