The study population will include 14 healthy or with mild iron deficiency women Other
Conditions
Interventions
The investigational product (i.e., one capsule of Monurelle® Ferro Naturale) will be administered once a day for 3 consecutive days. The investigational product will be orally administered in the morn
Sponsors
Zambon (Italy)
Eligibility
Sex/Gender
Female
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Informed consent: Written informed consent signed before study inclusion. 2. Sex and age: Women aged 18–60 years (inclusive). 3. BMI: Between 18.5 and 30 kg/m² (inclusive). 4. Vital signs: Systolic blood pressure 100–139 mmHg, diastolic blood pressure 50–89 mmHg, heart rate 50–99 bpm, measured after 5 minutes of seated rest. 5. Understanding and compliance: Ability to understand the nature, purpose, risks, and requirements of the study and to comply with all study procedures. 6. Serum iron: Between 4.0 and 12.0 µmol/L at screening. 7. Menstrual cycle: Women of childbearing potential must be in days 5–20 of their menstrual cycle during the interventional phase and must not have metrorrhagia. 8. Contraception and fertility: 8.1. Women of childbearing potential must use a reliable contraceptive method for at least 2 months prior to screening (hormonal methods, non-hormonal IUD, or barrier methods with spermicide), or have a sterile partner or a partner using a condom with spermicide. True abstinence is acceptable if consistent with the woman’s usual lifestyle. 8.2. Natural methods, lactational amenorrhea, and withdrawal are not acceptable. 8.3. Women who are not of childbearing potential or who have been postmenopausal for at least 1 year are eligible. 8.4. A negative pregnancy test is required at screening and on Day -1 for all participants.
Exclusion criteria
Exclusion criteria: 1. ECG: Clinically significant abnormalities on 12-lead ECG (supine position). 2. Physical examination: Clinically significant abnormal findings that, in the Investigator’s opinion, may interfere with the study objectives. 3. Laboratory tests: Clinically significant abnormal laboratory values indicating illness, particularly abnormal ferritin and/or CRP levels suggesting ongoing inflammation, that may affect study outcomes. 4. Allergy: Known or suspected hypersensitivity to study product ingredients; history of anaphylaxis to drugs or supplements, or significant allergic reactions that may impact the study. 5. Medical history: Significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, dermatological, hematological, endocrine, or neurological diseases that may interfere with the study. 6. Medications: Use of medications (including OTC drugs, herbal products, and nutritional supplements, especially iron supplements) within 2 weeks before study start that may affect study outcomes. Hormonal contraceptives are permitted. 7. Other clinical studies: Participation in another investigational product or device study within the previous 3 months (calculated from the first day of the month following the last visit of the previous study to the first day of the current study). 8. Blood donation: Blood donation within 3 months prior to the study. 9. Substance use: History (within the past 12 months) of drug abuse, alcohol consumption >1 drink/day, caffeine intake >5 cups of coffee/tea per day, or tobacco use =10 cigarettes/e-cigarettes per day. 10. Drug screening: Positive urine drug test at screening or Day -1. 11. Alcohol test: Positive alcohol test at screening or Day -1. 12. Diet: Abnormal diet (3500 kcal/day), significant dietary changes within 4 weeks prior to the study, or vegetarian diet. 13. Pregnancy/lactation: Positive or missing pregnancy test at screening or Day -1, or women who are pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic (PK) parameters baseline-corrected serum iron concentrations, including maximum concentration (Cmax), time to reach Cmax (tmax), terminal elimination rate constant (?z), half-life (t½ = ln2/?z), area under the curve from time zero to the last measurable concentration (AUC0–t), area under the curve extrapolated to infinity (AUC0–8), and the percentage of extrapolated AUC (%AUCextra), measured using Phoenix WinNonlin™ PK analysis at pre-dose (0) and 1, 2, 3, 4, 5, 8 h post-dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Product intake global evaluation and participant’s satisfaction measured using a short questionnaire at 3 h after each intake, from Day 1 to Day 3;Safety and tolerability, measured using adverse events recording, vital signs (blood pressure, heart rate), physical examinations, body weight, laboratory parameters and gastrointestinal tolerability, at screening and final visit for vital signs (blood pressure, heart rate), physical examinations, body weight, and laboratory parameters. Gastrointestinal tolerability will be assessed at day 1, 2 and 3. Adverse Events at all study visits. | — |
Countries
Switzerland
Contacts
Public ContactPietro Magrone
Outcome results
None listed