Trials / Completed
CompletedNCT00909571
Pharmacokinetics of Tacrolimus in Liver Transplantation Patients Treated With Prograf and Modified Release Tacrolimus
A Phase 3 Pilot Study to Describe the Pharmacokinetics of Tacrolimus in Patients Undergoing Primary Liver Donor Liver Transplantation Treated With Prograf Injection and Modified Release Tacrolimus Based Immunosuppressive Regimen
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- Astellas Pharma Inc · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Tacrolimus pharmacokinetics study in primary living donor liver transplantation patients with Tacrolimus based immunosuppressive regimens.
Detailed description
To describe the pharmacokinetics of Tacrolimus when administered as two different doses of modified release formulation FK506E(MR4) combined with Prograf injection in patients undergoing primary living donor liver transplantation based on the single center (Asan Medical Center) standard protocol regimen.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | FK506E (modified release tacrolimus) | oral |
| DRUG | Prograf (tacrolimus) | injection |
Timeline
- Start date
- 2009-04-01
- Primary completion
- 2010-03-01
- Completion
- 2010-03-01
- First posted
- 2009-05-28
- Last updated
- 2010-04-16
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT00909571. Inclusion in this directory is not an endorsement.