Difference of 12-hour AUC Clinical Trial
Official title:
Drug Interaction and Pharmacokinetic Assessment of Everolimus When Coadministered With Atorvastatin in Renal Transplantation Recipient
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.
Population : Thai postrenal transplantation recipient who received everolimus and have
hypercholesterolemia in posttransplantation clinic at Faculty of Medicine, Chulalongkorn
University.
Study Design : Experimental study, Two-sample crossover study Sample size calculation :N =
18 Primary outcome : 12-hour area under the time concentration curve of everolimus Secondary
outcome : renal function (serum creatinine, creatinine clearance)
Method :
1. Patients will random to everolimus or everolimus with atorvastatin 20 mg arm for 1
month.
2. Take blood sample for everolimus concentration at time 0,0.5, 1, 1.5, 2, 2.5, 4, 6, 8,
12 hour
3. After first blood sample, patients will received everolimus only for 1 month (wash out
period)
4. Patients will switch to another arm eg.patient who had received everolimus will switch
to everolimus with atorvastatin 20 mg for 1 month
5. Take blood sample for everolimus concentration at time 0,0.5, 1, 1.5, 2, 2.5, 4, 6, 8,
12 hour
6. Everolimus level will analyse for 12-hour AUC of everolimus.
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Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science