Healthy blood donors and anemic patients with inflammatory bowel disease MedDRA version: 14.1 Level: LLT Classification code 10002295 Term: Anemia iron deficiency System Organ Class: 100000004851
Conditions
Interventions
Product Name: Feramyl
Pharmaceutical Form: Concentrate and solvent for solution for injection
INN or Proposed INN: Iron (III) hydroxide hydroxyethyl starch glucopheptonic acid complex
CAS Number: CAS
Sponsors
SerumWerk Bernburg AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy volunteers: 1. Blood donor, who have donated 400 ml blood within the last 2 weeks. 2. The subject (male or female) is aged 18–45 years (inclusive). 3. The subject's body mass index is between 20 and 28 kg/m2 (inclusive). 4. The subject's systolic blood pressure is =65 years) yes F.1.3.1 Number of subjects for this age range 4
Exclusion criteria
Exclusion criteria: 1. Known allergy to Feramyl or HES. 2. The subject regularly takes multivitamin dietary supplement and/or iron supplement. (N.B. These will be prohibited during the study.) 3. The subject (if female) is pregnant or lactating. 4. The subject's laboratory values show any abnormality that the investigator considers to warrant exclusion of the subject from participation in the study. 5. The subject has any history (or current presence) of addiction to alcohol or drugs. 6. The subject has taken part in any other clinical trial within the previous three months 7 Severe IBD, surgery within the last 8 weeks, non-iron deficient anemia, iron overload or hemosiderosis, liver cirrhosis or hepatitis, acute or chronic infections, rheumatic disease, pregnancy or breastfeeding, planned elective surgery during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the dose dependency of Feramyl 200mg vs.Feramyl1000 mg administered over 1 hour intravenously with respect to Cmax, Tmax, T1/2and AUC. To evaluate the safety of 1a1-hour infusion time by monitoring of vital signs and, clinical chemical safety parameters and adverse events. ;Secondary Objective: To evaluate the Cmax, Tmax, AUC, half life, elimination constants, volumes of distribution and AUCurine excretion compared to literature data for competitors. To evaluate standard clinical chemical safety parameters and compare the results after 200 mg to 1000 mg and compare literature data for competitors. ;Primary end point(s): Not applicable | — |
Countries
Denmark
Contacts
Public ContactSøren Stroeh
aCROnordic
Outcome results
None listed