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

Iron Deficiency Anemia Clinical Trial

Official title:

Study of the Pharmacokinetics of Serum Iron After a Single Oral Administration of Ferrous Sulphate Supplement Synthetic Formula in Women With Iron Deficiency Anaemia.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02518568
• Other study ID #: V00355 CP 1 02
• Secondary ID: 2015-000544-42
• Status: Terminated
• Phase: Phase 1
• First received: August 4, 2015
• Last updated: September 27, 2016
• Start date: August 2015
• Est. completion date: May 2016

Study information

• Verified date: September 2016
• Source: Pierre Fabre Medicament
• Contact: n/a
• Is FDA regulated: No
• Health authority: Romania: Ethics CommitteeRomania: National Agency for Medicines and Medical DevicesBulgaria: Ethics committeeBulgaria: Bulgarian Drug Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 29
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Deficiency Diseases
• Iron Deficiency Anemia

Intervention

Drug:
• V0355
Oral administration (2 tablets)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pierre Fabre Medicament

Countries where clinical trial is conducted

Bulgaria,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Plasma concentration (Cmax)		up to 24 hours after oral administration	No
Primary	Time to Maximum Concentration (Tmax)		up to 24 hours after oral administration	No
Primary	Area under the iron plasma concentration curve (AUC)		up to 24 hours after oral administration	No
Secondary	Tolerability of single administration	Tolerability by evaluating the number of subjects with emergent adverse events	Up to 24 hours	Yes