Cross-over Study to Evaluate the Rate and the Extent of Iron Absorption of an ODF Iron Supplement vs an Iron Supplement in Capsules

Study Overview
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Brief Summary
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Open, monocentric, comparative, cross-over study to evaluate the rate and the extent of iron absorption after a single oral dose of (A) IBSA Iron orodispersible film vs (B) SiderAL® FORTE capsules in healthy women aged 18 to 55 years.

Detailed Description
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Open, monocentric, comparative cross-over study to compare the rate and the extent of iron absorption after a single oral dose of (A) IBSA Iron orodispersible film vs (B) SiderAL® FORTE capsules in healthy women aged 18 to 55 years. IBSA Iron is a food supplement based on ferric pyrophosphate and folic acid in orodispersible film. SiderAL® FORTE is a preparation based on ferric pyrophosphate and Vit.C in capsules. Each subject will be observed for two consecutive days (phase I, day -1 and day 0) and after a 7-day washout (phase II) for an additional two consecutive days (day -1 and day 0). Half of the enrolled subjects will take A in phase I and B in phase II; the remaining half of the enrolled subjects will take B in phase I and A in phase II. In the two days (day -1 and day 0) of both phases, peripheral blood samples will be taken and the defined parameters, indicative of blood iron levels, will be measured. The primary endpoint is the AUC0-t, Tmax and Cmax of serum iron. The secondary endpoints are the standard parameters indicative of blood iron levels.

Official Title
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Comparative Cross-over Study to Evaluate the Rate and the Extent of Iron Absorption of a New Iron Supplement (With Orodispersible Formulation) vs an Iron Supplement in Capsules, After Administration of a Single Dose in Healthy Volunteers

Conditions
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Iron-deficiency

Intervention / Treatment
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* Dietary Supplement: IBSA Iron ODF
* Dietary Supplement: SiderAL® FORTE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent signed prior to inclusion in the study; Women 18-55 years; Ability to understand the nature and the purpose of the study, including possible risks and side effects; Cability to collaborate with the investigator and meet the requirements of the entire study Exclusion Criteria: Smoke Clinically significant abnormalities in the ECG evaluation Clinically significant abnormal laboratory values indicative of disease Known allergy or presumed hypersensitivity to the food supplement investigated (iron) and / or to the excipients of the two formulations; History of anaphylaxis from drugs, dietary supplements or allergic reactions in general, which the investigator believed could influence the outcome of the study Significant history of kidney, liver, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that may interfere with the purpose of the study Taking herbal remedies and dietary supplements in the 2 weeks prior to the start of the study Taking corticosteroids, thyroid hormones, antibiotics, antiepileptics Alcohol abuse Any clinical condition that in the investigator's judgment is deemed incompatible with study participation Women who are pregnant or breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Single-dose, open-label, randomized, double-arm cross-over study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IBSA Iron ODF<br>A single dose of IBSA Iron ODF containing 30mg Iron and 400ug folic acid will be admistered to healthy female volounteers in one of the two consecutive study periods with a 7-day washout interval between the two administrations. | Dietary Supplement: IBSA Iron ODF<br>* IBSA Iron ODF is a food supplement based on ferric pyrophosphate and folic acid in orodispersible film. IBSA Iron ODF appears as a yellow, opaque, homogeneous film, without visible particles. Once taken, it dissolves on the tongue and can be swallowed without adding water.<br>|
| Active Comparator: SiderAL® FORTE<br>A single dose of SiderAL® FORTE containing 30mg Iron and 70mg vitamin C will be admistered to healthy female volounteers in one of the two consecutive study periods with a 7-day washout interval between the two administrations. | Dietary Supplement: SiderAL® FORTE<br>* Sideral® r.m. contained in SiderAL® FORTE is an iron protected with Sucrosomial® Technology which passes through the gastric environment intact and is absorbed in the intestine, thus preventing any irritation and discomfort to the stomach. The presence of Vitamin C facilitates the absorption of iron.<br>* Other names: Sucrosomial iron;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum plasma concentration of serum Iron | Maximum plasma concentration (Cmax) of serum iron to evaluate the rate of absorption of iron after a single oral dose of test versus reference | -24 hour, 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour | 
| Tmax of serum iron | Time to achieve Cmax (Tmax) after a single oral dose of test versus reference | -24 hour, 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour | 
| AUC0-8 of serum iron | Evaluation of area under the curve of serum iron up to 8h post-administration to evaluate the extent of iron absorption after a single oral dose of test versus reference | -24 hour, 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in blood concentration of hemoglobin | Evalution of the change from baseline of hemoglobin after administration of test versus reference product | -24 hour, 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour | 
| Change from baseline in blood concentration of hematocrit | Evalution of the change from baseline of hematocrit after administration of test versus reference product | -24 hour, 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour | 
| Change from baseline in blood concentration of ferritin | Evalution of the change from baseline of ferritin after administration of test versus reference product | -24 hour, 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour | 
| Change from baseline in blood concentration of transferrin | Evalution of the change from baseline of transferrin after administration of test versus reference product | -24 hour, 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour | 
| Change from baseline in blood concentration of transferrin receptor | Evalution of the change from baseline of transferrin receptor after administration of test versus reference product | -24 hour, 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour | 
| Change from baseline in blood concentration of folic acid | Evalution of the change from baseline of folic acid after administration of test versus reference product | -24 hour, 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour |