NCT02518568终止1 期
Study of the Pharmacokinetics of Serum Iron After a Single Oral Administration of Ferrous Sulphate Supplement Synthetic Formula in Women With Iron Deficiency Anaemia.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 29
- 主要终点
- Area under the iron plasma concentration curve (AUC)
研究概览
简要总结
The purpose of this study is to investigate the pharmacokinetics of serum iron after a single oral administration of 160 mg (2 tablets of 80 mg) V0355 in women with iron deficiency anaemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women 18-45 years inclusive with iron deficiency anaemia
- •haemoglobin level between 85 g/L and 105 g/L
- •serum ferritin level < 15 µg/L
- •D14 +/- 7 days of the menstruation cycle on the day of pharmacokinetic evaluation
排除标准
- •Anaemia related to other causes than iron deficiency and particularly inflammatory anaemia, anaemia due to marrow failure, haemopathy, haemoglobinopathies (sickle cell disease, thalassemia), haemolytic anaemia, anaemia due to acute haemorrhage, or anaemia related to chronic renal failure,
- •Haemochromatosis or iron overload of secondary origin (blood transfusion),
- •Long term treatment known to modify iron absorption,
- •Gastro duodenal ulcer,
- •Inflammatory bowel disease or any digestive disease which could modify iron absorption,
- •Serious or progressive disease (cardiac, pulmonary, hepatic, renal, haematological, malignancy, autoimmune disease, infectious disease or neuropsychiatric disorders),
- •Surgery undergone within 1 month prior to selection visit or a surgery planned during the study realization.
研究组 & 干预措施
Drug
Experimental
干预措施: V0355 (Drug)
结局指标
主要结局
Area under the iron plasma concentration curve (AUC)
时间窗: up to 24 hours after oral administration
Maximum Plasma concentration (Cmax)
时间窗: up to 24 hours after oral administration
Time to Maximum Concentration (Tmax)
时间窗: up to 24 hours after oral administration
次要结局
- Tolerability of single administration(Up to 24 hours)
研究者
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