Ferrous Sulphate Supplement in Women With Iron Deficiency Anaemia

NCT01757119 | Completed Phase 1

• 2 other identifiers: L00008 CP 1 012012-002190-63
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 2

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.

Conditions

Iron Deficiency Anemia

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic profile of serum iron after single oral administration of ferrous sulphate supplement

  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.

  Up to 24 hours

Secondary Outcomes (1)

• Tolerability of single administration (reported adverse events)

  Up to 24 hours

Study Arms (1)

Drug

EXPERIMENTAL

Drug: Tardyferon 80 mg

Interventions

Tardyferon 80 mg DRUG

Oral administration (2 tablets)

Drug

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Pierre Fabre Medicament: lead

Study Sites (2)

Unknown Facility

Iași, Romania

Location

Unknown Facility

Timișoara, 300244, Romania

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

ferrous sulfate, mucin drug combination

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2012
• First Posted: December 28, 2012
• Study Start: January 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: April 15, 2014

Record last verified: 2014-04

Locations

RO (2)