Trials / Completed
CompletedNCT01666951
Multicenter, Prospective, Rand, PK Study of LCP-Tacro™ Compared to Prograf® Capsules in De Novo Adult Kidney Transplant
Ph 2 Double-blind, Double-dummy, Multicenter, Prospective, Rand Study of PK of LCP-Tacro™ Tablets Once Daily, Compared to Prograf® Caps, Twice Daily, for Prevention of Acute Allograft Rejection in De Novo Adult Kidney Transplant Recipients
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- Veloxis Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the pharmacokinetics of LCP-Tacro tablets administered once-daily compared to Prograf capsules administered twice-daily after kidney transplantation.
Detailed description
This is a 2-arm , parallel group, prospective, double-blind, double-dummy, multicenter,clinical trial to evaluate the pharmacokinetics of LCP-Tacro tablets once daily in comparison to Prograf capsules twice-daily after kidney transplantation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | LCP-Tacro tablets | Tacrolimus |
| DRUG | Prograf | Tacrolimus |
Timeline
- Start date
- 2012-11-01
- Primary completion
- 2013-03-01
- Completion
- 2013-05-01
- First posted
- 2012-08-16
- Last updated
- 2015-07-07
- Results posted
- 2015-07-07
Locations
13 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01666951. Inclusion in this directory is not an endorsement.