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NCT01256294 · ClinicalTrials.gov registry record · Phase 4
Pharmacokinetics of Generic to Brand Tacrolimus in Stable Renal Transplant Patients
A Phase 4 study, sponsored by Novartis.
- Completed
- Registry status
- Phase 4
- Development phase
- 71
- Enrollment target
NCT01256294 is a Phase 4 study that has completed, run by Novartis. The registered enrollment target is 71 participants.
The verdict
NCT01256294, a Phase 4 study, has completed, sponsored by Novartis.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 71 participants
- Enrollment target
Study Summary
The study is designed to compare the pharmacokinetics of generic tacrolimus (Sandoz) to branded tacrolimus (Prograf) in stable renal transplant patients.
Interventions
- DRUG Generic Tacrolimus
- DRUG Branded Tacrolimus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2010-10 |
| Est. Completion | 2011-05 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01256294
The ClinicalTrials.gov registry entry for NCT01256294 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 71 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis, which has 265 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Generic Tacrolimus is the first listed.
NCT01256294 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01256294 about?
NCT01256294 is a clinical study titled "Pharmacokinetics of Generic to Brand Tacrolimus in Stable Renal Transplant Patients". The study is designed to compare the pharmacokinetics of generic tacrolimus (Sandoz) to branded tacrolimus (Prograf) in stable renal transplant patients.
What is the current status of trial NCT01256294?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 71 participants. The study started on 2010-10. Estimated completion is 2011-05.
What interventions are being tested in trial NCT01256294?
The interventions under investigation include: Generic Tacrolimus (DRUG), Branded Tacrolimus (DRUG).
Who is sponsoring clinical trial NCT01256294?
This trial is sponsored by Novartis, which has 265 total clinical trials registered on ClinicalTrials.gov.
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