Trial Details
Not RecruitingBasic Information
| Clinical ID | c3144 |
|---|---|
| Identifier | EUCTR2013-001123-39-DK |
| Trial Title | An open label study on safety and pharmacokinetics of an intravenous administered single dose of Feramyl 200 mg in healthy blood donors compared to a single dose of Feramyl 1000 mg in IBD patients to evaluate dose dependency and kinetics after 1 hour infusion. |
| Trial URL | Visit Original Page |
Study Information
| Study Results | No results available |
|---|---|
| Conditions | 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_;Therapeutic area: Not possible to specify |
| 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 15 Current Sponsor code: 03-01-0056 Other descriptive name: Iron HES Complex Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50- |
Participant Information
| Sponsor | SerumWerk Bernburg AG |
|---|---|
| City | - |
| Country/Region | Denmark |
Enrollment Criteria
| Sex Requirement | NOT SPECIFIED |
|---|---|
| Age Requirement | - |
Study Design
| Study Type | Interventional clinical trial of medicinal product |
|---|---|
| Phase | Not Available |
Time Information
| Start Date | 2025-04-24 |
|---|---|
| Primary Completion Date | - |
| Completion Date | - |