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

Phase 1

Terminated

• Conditions: Iron Deficiency Anemia
• Interventions: Drug: V0355

• Registration Number: NCT02518568
• Lead Sponsor: Pierre Fabre Medicament

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-08-04
• Study First Submitted QC: 2015-08-05
• Study First Posted: 2015-08-10
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-27
• Last Update Posted: 2016-09-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 29

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Drug	V0355	-

Primary Outcome Measures

Name	Time	Method
Area under the iron plasma concentration curve (AUC)	up to 24 hours after oral administration
Time to Maximum Concentration (Tmax)	up to 24 hours after oral administration
Maximum Plasma concentration (Cmax)	up to 24 hours after oral administration

Secondary Outcome Measures

Name	Time	Method
Tolerability of single administration	Up to 24 hours	Tolerability by evaluating the number of subjects with emergent adverse events