Trials / Completed
CompletedNCT01256294
Pharmacokinetics of Generic to Brand Tacrolimus in Stable Renal Transplant Patients
A Prospective, Multi-center, Open-label, Randomized, Two Period, Two Sequence, Crossover Study to Compare the Steady State Pharmacokinetics of Generic Tacrolimus (Sandoz) to Prograf in Stable Renal Transplant Patients
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 71 (actual)
- Sponsor
- Novartis · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The study is designed to compare the pharmacokinetics of generic tacrolimus (Sandoz) to branded tacrolimus (Prograf) in stable renal transplant patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Generic Tacrolimus | Generic Sandoz tacrolimus supplied as capsules of 0.5 mg, 1 mg and 5 mg dose strengths. |
| DRUG | Branded Tacrolimus | Capsules supplied at dose strengths of 0.5 mg, 1 mg, and 5 mg. |
Timeline
- Start date
- 2010-10-01
- Primary completion
- 2011-05-01
- Completion
- 2011-05-01
- First posted
- 2010-12-08
- Last updated
- 2012-06-21
- Results posted
- 2012-06-21
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01256294. Inclusion in this directory is not an endorsement.