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Pharmacokinetic of Everolimus and Atorvastatin Co-administration

NCT01780948 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2013-02-08

No results posted yet for this study

Summary

Hypothesis : In renal transplantation recipient who received immunosuppressive drug "certican" and have hypercholesterolemia will get lipid lower drug-HMG Co-A reductase inhibitors. Because atorvastatin and everolimus have metabolism via Cytochrome P450 subfamily 3A4 both, so investigator made the hypothesis that when patients received everolimus with atorvastatin will change area under the time concentration curve of everolimus.

Conditions

  • Difference of 12-hour AUC

Interventions

DRUG

Atorvastatin 20 mg

Add atorvastatin 20 mg and compare 12-hour AUC of everolimus between Arm everolimus and everolimus with atorvastatin 20 mg

DRUG

Everolimus

Administration only everolimus, no atorvastatin. Everolimus administration with adjusted dose to target C trough (C0)level between 3-12 ng/mL.

Sponsors & Collaborators

  • Ratchadapiseksompotch Research Fund

    collaborator UNKNOWN

  • Chulalongkorn University

    lead OTHER

Principal Investigators

  • Anocha Wanitchanont, MD. · Chulalongkorn University

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • Thailand

Study Locations

More Related Trials

Entities

Drugs

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 NCT01780948 on ClinicalTrials.gov