Ferrous Sulphate Supplement in Women With Iron Deficiency Anaemia

Study Overview
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Brief Summary
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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.

Official Title
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Study of the Pharmacokinetics of Serum Iron After Single Oral Administration of Ferrous Sulphate Supplement in Women With Iron Deficiency Anaemia

Conditions
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Iron Deficiency Anemia

Intervention / Treatment
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* Drug: Tardyferon 80 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: - 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug<br> | Drug: Tardyferon 80 mg<br>* Oral administration (2 tablets)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic profile of serum iron after single oral administration of ferrous sulphate supplement | 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. | Up to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability of single administration (reported adverse events) | Tolerability by evaluating the number of subjects with emergent adverse events | Up to 24 hours |