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| Name | Class |
|---|---|
| Informapro Srl | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBSA Iron ODF | Experimental | 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. |
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| SiderAL® FORTE | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBSA Iron ODF | Dietary Supplement | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Silvia Angeletti | Operative Research Unit of Clinical Laboratory | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Universitario Campus Bio-Medico di Roma | Roma | 00128 | Italy |
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| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C000718012 | sucrosomial iron |
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Single-dose, open-label, randomized, double-arm cross-over study
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No masking procedure will be applied
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| SiderAL® FORTE | Dietary Supplement | 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. |
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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 |
| D000090463 |
| Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |