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Completed
NCT05660200
Cross-over Study to Evaluate the Rate and the Extent of Iron Absorption of an ODF Iron Supplement vs an Iron Supplement in Capsules
Conditions: Iron-deficiency
Sex: Female
Ages: 18 Years – 55 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 9
Sponsor: IBSA Farmaceutici Italia Srl
Location: Italy
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.
Eligibility Criteria
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 studyExclusion Criteria:SmokeClinically significant abnormalities in the ECG evaluationClinically significant abnormal laboratory values indicative of diseaseKnown 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 studySignificant history of kidney, liver, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that may interfere with the purpose of the studyTaking herbal remedies and dietary supplements in the 2 weeks prior to the start of the studyTaking corticosteroids, thyroid hormones, antibiotics, antiepilepticsAlcohol abuseAny clinical condition that in the investigator's judgment is deemed incompatible with study participationWomen who are pregnant or breastfeeding
Source: ClinicalTrials.gov (NCT05660200). StuddyBuddy aggregates publicly available trial information.
