Ferrous Sulphate Supplement in Women With Iron Deficiency Anaemia

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01757119

Enrollment

Registered

2012-12-28

Start date

2013-01-31

Completion date

2014-03-31

Last updated

2014-04-15

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 (the amount of iron in blood) after single oral administration of 2 tablets of L0008 80 mg (as ferrous sulphate) in women with iron deficiency anaemia.

Interventions

DRUGTardyferon 80 mg

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 old 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 * Standard diet

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, * Fructose intolerance, syndrome of malabsorption of glucose, galactose, deficit of sucrase-isomaltase, * 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	Description
Pharmacokinetic profile of serum iron after single oral administration of ferrous sulphate supplement	Up to 24 hours	Pharmacokinetic profile of serum iron after single oral administration of ferrous sulphate supplement by measuring Maximum Plasma concentration, Time of Maximum Concentration, Area under the iron plasma concentration curve.

Secondary

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

Countries

Romania

Outcome results

None listed

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