NCT01757119已完成1 期
Study of the Pharmacokinetics of Serum Iron After Single Oral Administration of Ferrous Sulphate Supplement 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
- 已完成
- 入组人数
- 55
- 主要终点
- Pharmacokinetic profile of serum iron after single oral administration of ferrous sulphate supplement
研究概览
简要总结
The purpose of this study is to investigate the pharmacokinetics of serum iron (the amount of iron in blood) after single oral administration of 2 tablets of L0008 80 mg (as ferrous sulphate) 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 old 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
- •Standard diet
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,
- •Fructose intolerance, syndrome of malabsorption of glucose, galactose, deficit of sucrase-isomaltase,
- •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: Tardyferon 80 mg (Drug)
结局指标
主要结局
Pharmacokinetic profile of serum iron after single oral administration of ferrous sulphate supplement
时间窗: Up to 24 hours
Pharmacokinetic profile of serum iron after single oral administration of ferrous sulphate supplement by measuring Maximum Plasma concentration, Time of Maximum Concentration, Area under the iron plasma concentration curve.
次要结局
- Tolerability of single administration (reported adverse events)(Up to 24 hours)
研究者
相似试验
终止
1 期
Ferrous Sulphate Supplement (V0355) in Women With Iron Deficiency AnaemiaIron Deficiency AnemiaNCT02518568Pierre Fabre Medicament29
已完成
1 期
Pharmacokinetics and Absolute Bioavailability of Fer-In-Sol and Triferic Administered Orally With Shohl's Solution in Healthy VolunteersIron-refractory, Iron-deficiency Anemia (IRIDA)NCT02767128Rockwell Medical Technologies, Inc.14
已完成
1 期
Pharmacokinetics and Preliminary Bioequivalence of Triferic (Ferric Pyrophosphate Citrate) Administered Via Hemodialysate and Intravenously to Adult CKD-5HD PatientsEnd Stage Renal DiseaseNCT02739100Rockwell Medical Technologies, Inc.13
已完成
不适用
Impact of Iron Supplementation Treatment on Brain Iron ConcentrationsADHDIron-deficiencyRestless Legs SyndromePeriodic Limb Movement Sleep DisorderNCT04144790Hugo W. Moser Research Institute at Kennedy Krieger, Inc.12
撤回
不适用
Effects of Iron Therapy and Exercise Training in Patients With Heart Failure and Iron DeficiencyHeart Failure With Reduced Ejection FractionExercise TrainingFerric CarboxymaltoseNCT03803111Herzzentrum Bremen