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

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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02518568

Enrollment

Registered

2015-08-10

Start date

2015-08-31

Completion date

2016-05-31

Last updated

2016-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron Deficiency Anemia

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.

Interventions

DRUGV0355

Oral administration (2 tablets)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Tolerability of single administration	Up to 24 hours	Tolerability by evaluating the number of subjects with emergent adverse events

Countries

Bulgaria, Romania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026