Pilot comparative bioavailability study of sublingual administration of Iron Citrate versus SiderAL Forte® in healthy male volunteers

Biofer S.p.A.0 个研究点目标入组 7 人开始时间: 2016年2月5日最近更新: 2016年10月17日

适应症

试验速览

暂无简介。

•1. Informed consent: signed written informed consent before inclusion in the study
•2. Sex and Age: males, 18-55 years old inclusive
•3. Body Mass Index (BMI): 18.5-30 kg/m2 inclusive
•4. Vital signs: systolic blood pressure (SBP) 100-139 mmHg, diastolic blood pressure (DBP) 50-89 mmHg, heart rate (HR) 50-90 bpm, measured after 5 min at rest in the sitting position
•5. Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the entire study

•Electrocardiogram (ECG) 12-leads (supine position): clinically significant abnormalities
•2. Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study
•3. Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness
•4. Allergy: ascertained or presumptive hypersensitivity to the investigated nutritional product (iron) and/or formulations' ingredients (e.g. vitamin C); history of anaphylaxis to drugs, nutritional supplements or allergic reactions in general, which the investigator considered could affect the outcome of the study
•5. Diseases: significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that could interfere with the aim of the study
•6. Medications: medications, including over the counter (OTC) medications, herbal remedies and nutritional supplements for 2 weeks before the start of the study

发起方

Biofer S.p.A.