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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- AUC0-8 of serum iron
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
盲法说明
No masking procedure will be applied
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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 study
排除标准
- •Clinically significant abnormalities in the ECG evaluation
- •Clinically significant abnormal laboratory values indicative of disease
- •Known 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 study
- •Significant history of kidney, liver, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that may interfere with the purpose of the study
- •Taking herbal remedies and dietary supplements in the 2 weeks prior to the start of the study
- •Taking corticosteroids, thyroid hormones, antibiotics, antiepileptics
- •Alcohol abuse
- •Any clinical condition that in the investigator's judgment is deemed incompatible with study participation
- •Women who are pregnant or breastfeeding
研究组 & 干预措施
IBSA Iron ODF
A single dose of IBSA Iron ODF containing 30mg Iron and 400ug folic acid will be admistered to healthy female volounteers in one of the two consecutive study periods with a 7-day washout interval between the two administrations.
干预措施: IBSA Iron ODF (Dietary Supplement)
SiderAL® FORTE
A single dose of SiderAL® FORTE containing 30mg Iron and 70mg vitamin C will be admistered to healthy female volounteers in one of the two consecutive study periods with a 7-day washout interval between the two administrations.
干预措施: SiderAL® FORTE (Dietary Supplement)
结局指标
主要结局
AUC0-8 of serum iron
时间窗: -24 hour, 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour
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
Maximum plasma concentration of serum Iron
时间窗: -24 hour, 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour
Maximum plasma concentration (Cmax) of serum iron to evaluate the rate of absorption of iron after a single oral dose of test versus reference
Tmax of serum iron
时间窗: -24 hour, 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour
Time to achieve Cmax (Tmax) after a single oral dose of test versus reference
次要结局
- Change from baseline in blood concentration of transferrin(-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(-24 hour, 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour)
- Change from baseline in blood concentration of hematocrit(-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(-24 hour, 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour)
- Change from baseline in blood concentration of hemoglobin(-24 hour, 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour)
- Change from baseline in blood concentration of ferritin(-24 hour, 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour)