Ferrous Sulphate Supplement (V0355) in Women With Iron Deficiency Anaemia

• Status: Terminated
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pierre Fabre Medicament

Criteria

Inclusion Criteria:

• 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

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,

• 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.