Trials / Completed
CompletedNCT01698541
Generic Tacrolimus in the Elderly - Prograf® vs Tacni®
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 28 (actual)
- Sponsor
- University of Oslo School of Pharmacy · Academic / Other
- Sex
- All
- Age
- 60 Years
- Healthy volunteers
- Not accepted
Summary
Test bioequivalence of generic tacrolimus (Tacni), using original tacrolimus (Prograf) as comparator, in elderly (\>60 yr) renal transplant recipients
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tacrolimus | Tested generic |
| DRUG | Tacrolimus | Original formulation used as comparator |
Timeline
- Start date
- 2013-02-01
- Primary completion
- 2013-11-01
- Completion
- 2013-11-01
- First posted
- 2012-10-03
- Last updated
- 2014-12-03
Locations
1 site across 1 country: Norway
Source: ClinicalTrials.gov record NCT01698541. Inclusion in this directory is not an endorsement.