drugset / Trial / NCT02130414
PK, Safety & Tolerability of CyCol® Versus Sandimmune® in Healthy Subjects
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The aim of this Phase I, single centre, multi stage study is to evaluate the safety, tolerability, pharmacokinetics and relative colonic mucosal concentrations of cyclosporine capsules (CyCol®) compared to intravenous cyclosporine in healthy male volunteers.
Timeline
- Start
- 2014-07
- Primary completion
- 2015-01
- Completion
- 2015-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cyclosporine | Peptide | 2 mg/kg | Intravenous |
| Comparator | Cyclosporine | Peptide | 37.5 mg | Intravenous |
| Comparator | Cyclosporine | Peptide | 75 mg | Intravenous |
| Comparator | Cyclosporine | Peptide | 150 mg | Intravenous |
Indications
No indication recorded.