Trial Details
Not RecruitingBasic Information
| Clinical ID | c5397 |
|---|---|
| Identifier | CTRI/2011/12/002304 |
| Trial Title | A Open-label pharmacokinetic study of iron isomaltoside 1000 (Monofer) administered by 500 mg IV bolus injection or 1000 mg intravenous infusion to subjects with Inflammatory Bowel Disease - none |
| Trial URL | Visit Original Page |
Study Information
| Study Results | NULL |
|---|---|
| Conditions | Health Condition 1: null- Inflammatory Bowel Disease (IBD) with iron deficiency anemia. |
| Interventions | Intervention1: Iron isomaltoside 1000 (Monofer: Administered as 500 mg intravenous bolus injectionsFrequency :- OnceDuration:- Once in studyIntervention2: Iron isomaltoside 1000 (Monofer: Administered as 1000 mg intravenous infusions F |
Participant Information
| Sponsor | Pharmacosmos AS |
|---|---|
| City | NULL |
| Country/Region | India |
Enrollment Criteria
| Sex Requirement | NOT SPECIFIED |
|---|---|
| Age Requirement | NULL |
Study Design
| Study Type | Interventional |
|---|---|
| Phase | PHASE3 |
Time Information
| Start Date | NULL |
|---|---|
| Primary Completion Date | NULL |
| Completion Date | NULL |