Ignite Creation Date:
2024-05-06 @ 6:26 PM
Last Modification Date:
2024-10-26 @ 2:48 PM
Study NCT ID:
NCT05660200
Status:
COMPLETED
Last Update Posted:
2023-01-11
First Post:
2022-12-12
Brief Title:
Cross-over Study to Evaluate the Rate and the Extent of Iron Absorption of an ODF Iron Supplement vs an Iron Supplement in Capsules
Sponsor:
IBSA Farmaceutici Italia Srl
Organization:
IBSA Farmaceutici Italia Srl
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 VitC 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
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 VitC 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None