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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
9
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.
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.
Fondazione Policlinico Universitario Campus Bio-Medico di Roma
Roma, Italy
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
Time frame: -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
Time frame: -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
Time frame: -24 hour, 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour
Change from baseline in blood concentration of hemoglobin
Evalution of the change from baseline of hemoglobin after administration of test versus reference product
Time frame: -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
Time frame: -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
Time frame: -24 hour, 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour
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Change from baseline in blood concentration of transferrin
Evalution of the change from baseline of transferrin after administration of test versus reference product
Time frame: -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
Time frame: -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
Time frame: -24 hour, 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour