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

Iron-deficiency Clinical Trial

Official title:
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

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05660200
Study type Interventional
Source IBSA Farmaceutici Italia Srl
Contact
Status Completed
Phase N/A
Start date November 25, 2022
Completion date December 31, 2022
View Details
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