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

Pierre Fabre

Status and phase

Terminated

Phase 1

Conditions

Iron Deficiency Anemia

Treatments

Drug: V0355

Study type

Interventional

Funder types

Industry

Identifiers

NCT02518568

2015-000544-42 (EudraCT Number)

V00355 CP 1 02

Details and patient eligibility

About

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.

Enrollment

29 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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.