Prospective, Rand, Open-label, Single-center, 2 Sequence, 3 Period Crossover Study to Compare the Steady State PK of Once-Daily-Extended Release LCP-Tacro to Generic Tacrolimus Capsules Twice Daily in Stable A A Renal Transplant pt.

Trial Profile

Prospective, Rand, Open-label, Single-center, 2 Sequence, 3 Period Crossover Study to Compare the Steady State PK of Once-Daily-Extended Release LCP-Tacro to Generic Tacrolimus Capsules Twice Daily in Stable A A Renal Transplant pt.

Completed
Phase of Trial: Phase III

Latest Information Update: 16 Aug 2016

At a glance

  • Drugs Tacrolimus (Primary)
  • Indications Renal transplant rejection
  • Focus Pharmacokinetics; Registrational
  • Acronyms ASERTAA
  • Sponsors Veloxis Pharmaceuticals
  • Most Recent Events

    • 07 Jun 2017 Biomarkers information updated
    • 29 Jun 2016 According to a Veloxis Pharmaceuticals media release, based on the findings from this study the company has received approval for label enhancement for the Envarsus (Tacrolimus extended-release) package insert. The FDA-approved label now contains ethnicity-specific dosing and unique genotyping guidance to Envarsus XR.
    • 29 Jun 2016 Results published in a Veloxis Pharmaceuticals media release.
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