Pharmacokinetics of LCP-Tacro in Stable Liver Transplant Patients

Status Completed

Clinical Trial Summary

Clinical Trial Description

A three sequence, open-label, multi-center, prospective, study in stable liver transplant patients to assess and compare the pharmacokinetics (Cmax, C24, and AUC), and safety of LCP-Tacro (tacrolimus) tablets versus Prograf (tacrolimus) capsules.

Stable liver transplant patients who fulfill all I/E criteria will be enrolled and kept on Prograf for 7 days. Following a 24-hour PK study on Day 7 to determine pharmacokinetics for Prograf, all patients will be converted to once daily LCP-Tacro for 14 days with one fixed dose change allowed at Day 15.

On Day 14 and Day 21 a 24-hour LCP-Tacro PK study will be performed. On Day 22 patients will be converted back to their original twice daily dose of Prograf for a safety follow-up period of 30 days ending with a safety assessment on day 53. ;

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Liver Failure

Clinical Trial Details

NCT number	NCT00608244
Study type	Interventional
Source	Veloxis Pharmaceuticals
Contact
Status	Completed
Phase	Phase 2
Start date	November 2007
Completion date	June 2008

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