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TerminatedNCT02518568Updated Sep 28, 2016

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

A Phase 1 interventional study of V0355 in Iron Deficiency Anemia, sponsored by Pierre Fabre Medicament. Terminated at 2 sites in 2 countries. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2016-09-28.

Sponsored by Pierre Fabre Medicament · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
29
Allocation
Not applicable
Ages
18 Years to 45 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Iron Deficiency Anemia
03

In context

Anemia

1,733 studies on the registry are indexed under Anemia; 246 are open to participants now.

This study's enrollment of 29 is below the median of 94 across 1,291 interventional studies indexed under Anemia.

Browse Anemia studies →

Lead sponsor

Pierre Fabre Medicament is the lead sponsor of 71 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
29 participants (actual)

Study arms

  • Experimental
    Drug

    Drug: V0355

Interventions

  • DrugV0355

    Oral administration (2 tablets)

06

What researchers measure

Primary outcomes

  1. Maximum Plasma concentration (Cmax)

    Time frame: up to 24 hours after oral administration

  2. Time to Maximum Concentration (Tmax)

    Time frame: up to 24 hours after oral administration

  3. Area under the iron plasma concentration curve (AUC)

    Time frame: up to 24 hours after oral administration

Secondary outcomes

  1. Tolerability of single administration

    Tolerability by evaluating the number of subjects with emergent adverse events

    Time frame: Up to 24 hours

07

Study locations

2 sites
  • Sofia, Bulgaria
  • Iasi, Romania
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 28, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02518568
Lead sponsor
Pierre Fabre Medicament
Responsible party
Sponsor
First posted
Aug 10, 2015
Start date
Aug 2015
Primary completion
May 2016
Completion
May 2016
Last update
Sep 28, 2016
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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