drugset / Trial / NCT00496483
Pharmacokinetics of LCP-Tacro in Stable Kidney Transplant Patients
Phase 2
Completed
60 enrolled
Veloxis Pharmaceuticals
CTI Clinical Trial and Consulting Services · collab
NaSingle-groupOpen-labelTreatment
Summary
A three sequence, open-label, multi-center, prospective, study in stable kidney transplant patients to assess and compare the pharmacokinetics (Cmax, C24, and AUC), and safety of LCP-Tacro (tacrolimus) tablets versus Prograf (tacrolimus) capsules.
Timeline
- Start
- 2007-07
- Primary completion
- 2008-03
- Completion
- 2008-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Tacrolimus | Small molecule | 1 mg | Oral |
| Comparator | Tacrolimus | Small molecule | 2 mg | Oral |
| Comparator | Tacrolimus | Small molecule | 5 mg | Oral |