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| Name | Class |
|---|---|
| Oslo University Hospital | OTHER |
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Test bioequivalence of generic tacrolimus (Tacni), using original tacrolimus (Prograf) as comparator, in elderly (>60 yr) renal transplant recipients
12-hour pharmacokinetic investigations performed on each formulation in each patient at steady-state. Patients will be randomized with regards to which formulation to start with. 1-2 weeks between each PK investigation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tacni | Experimental | Tacrolimus administered as generic formulation Tacni in accordance with standard protocol at the transplant center |
|
| Prograf | Active Comparator | Tacrolimus administered as Prograf in according to standard protocol at the transplant center |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tacrolimus | Drug | Tested generic |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Population model validation | Use these new patient data to verify previously developed population pharmacokinetic model for tacrolimus. | 10 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anders Ã…sberg, PhD | University of Oslo | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital, Rikshospitalet | Oslo | 0027 | Norway |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| Tacrolimus | Drug | Original formulation used as comparator |
|
|
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |