MedTrace Logo

Crossover Study to Compare PK of Once Daily LCP-Tacro Tablets to Generic Tacrolimus Capsules Twice Daily.

NCT01962922 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2018-06-06

Study results available
· View outcomes & findings →

Summary

Open label, prospective, single-center, randomized, two sequence, three period crossover study to compare the steady state pharmacokinetics of LCP-Tacro tables to generic tacrolimus capsules administered twice daily in stable African-American renal transplant patients.

Conditions

  • Renal Failure

Interventions

DRUG

LCP-Tacro

once-daily extended release tablet

DRUG

Tacrolimus -IR

twice daily capsules

Sponsors & Collaborators

  • Veloxis Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Leslie Callahan, RN · Veloxis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2015-07-31
Completion
2015-08-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01962922 on ClinicalTrials.gov