- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02518568
Ferrous Sulphate Supplement (V0355) in Women With Iron Deficiency Anaemia
September 27, 2016 updated by: Pierre Fabre Medicament
Study of the Pharmacokinetics of Serum Iron After a Single Oral Administration of Ferrous Sulphate Supplement Synthetic Formula in Women With Iron Deficiency Anaemia.
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
29
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Drug
|
Oral administration (2 tablets)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximum Plasma concentration (Cmax)
Time Frame: up to 24 hours after oral administration
|
up to 24 hours after oral administration
|
Time to Maximum Concentration (Tmax)
Time Frame: up to 24 hours after oral administration
|
up to 24 hours after oral administration
|
Area under the iron plasma concentration curve (AUC)
Time Frame: up to 24 hours after oral administration
|
up to 24 hours after oral administration
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tolerability of single administration
Time Frame: Up to 24 hours
|
Tolerability by evaluating the number of subjects with emergent adverse events
|
Up to 24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2015
Primary Completion (ACTUAL)
May 1, 2016
Study Completion (ACTUAL)
May 1, 2016
Study Registration Dates
First Submitted
August 4, 2015
First Submitted That Met QC Criteria
August 5, 2015
First Posted (ESTIMATE)
August 10, 2015
Study Record Updates
Last Update Posted (ESTIMATE)
September 28, 2016
Last Update Submitted That Met QC Criteria
September 27, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- V00355 CP 1 02
- 2015-000544-42 (EUDRACT_NUMBER)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Iron Deficiency Anemia
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Pennington Biomedical Research CenterRecruitingIron-deficiency | Iron Deficiency Anemia | Iron Deficiency Anemia TreatmentUnited States
-
Children's Hospital Los AngelesNot yet recruitingAnemia | Iron Deficiency Anemia | Anemia, Iron Deficiency | IDA - Iron Deficiency AnemiaUnited States
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King's CollegeCompletedIron-deficiency | Iron Deficiency Anemia | Iron Deficiency (Without Anemia)United States
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Arrowhead Regional Medical CenterRecruitingIron Deficiency Anemia of PregnancyUnited States
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Swiss Federal Institute of TechnologyUnited States Agency for International Development (USAID); Quadram Institute... and other collaboratorsCompletedIron-deficiency | Iron Deficiency Anemia | Iron Deficiency (Without Anemia)Peru
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Baylor College of MedicineNational Heart, Lung, and Blood Institute (NHLBI)CompletedIron-deficiency | Iron Deficiency AnemiaUnited States
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Iowa State UniversityCompletedIron-deficiency | Iron Deficiency Anemia | Iron Deficiency Anemia Treatment | Iron Deficiency Anaemia Due to Dietary CausesUnited States
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