| Trial ID: | L0897 |
| Source ID: | NCT01698541
|
| Associated Drug: |
Tacrolimus
|
| Title: |
Generic Tacrolimus in the Elderly - Prograf® vs Tacni®
|
| Acronym: |
GenTac
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
End Stage Renal Disease
|
| Interventions: |
DRUG: Tacrolimus|DRUG: Tacrolimus
|
| Outcome Measures: |
Primary: Bioequivalence, Bioequivalence will be assessed at steady-state by comparing both AUC(0-12) and Cmax ratios for generic:original-ratios and applying the stricter 90-111% bioequivalence criteria. AUC(0-12) will be assessed by trapezoidal rule and Cmax will be the highest actually measured concentration., 10 weeks | Secondary: Population model validation, Use these new patient data to verify previously developed population pharmacokinetic model for tacrolimus., 10 weeks
|
| Sponsor/Collaborators: |
Sponsor: University of Oslo School of Pharmacy | Collaborators: Oslo University Hospital
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
28
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2013-02
|
| Completion Date: |
2013-11
|
| Results First Posted: |
|
| Last Update Posted: |
2014-12-03
|
| Locations: |
Oslo University Hospital, Rikshospitalet, Oslo, 0027, Norway
|
| URL: |
https://clinicaltrials.gov/show/NCT01698541
|
