Kidney transplantation
Conditions
Brief summary
AUC0-12 and Cmax of tacrolimus/mycophenolate with:without (calcium supplement coadministration) ratio (according to EMA bioequivalence guidelines)
Detailed description
Tacrolimus pharmacokinetic parameters and variables such as AUC0-12, Cmax, Fabs, C0, C12, CL, popPK model parameters, Mycophenolate mofetil pharmacokinetic parameters and variables such as AUC0-12, Cmax, Fabs, C0, C12, CL, popPK model parameters, Prednisolone pharmacokinetic parameters and variables such as AUC0-12, Cmax, Fabs, C0, C12, CL, popPK model parameters, Metagenomic feces analyses, feces derived ex vivo drug conversion rates
Interventions
DRUGCalcigran Forte 500 mg/400 IE tyggetabletter
Sponsors
Oslo University Hospital HF
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC0-12 and Cmax of tacrolimus/mycophenolate with:without (calcium supplement coadministration) ratio (according to EMA bioequivalence guidelines) | — |
Secondary
| Measure | Time frame |
|---|---|
| Tacrolimus pharmacokinetic parameters and variables such as AUC0-12, Cmax, Fabs, C0, C12, CL, popPK model parameters, Mycophenolate mofetil pharmacokinetic parameters and variables such as AUC0-12, Cmax, Fabs, C0, C12, CL, popPK model parameters, Prednisolone pharmacokinetic parameters and variables such as AUC0-12, Cmax, Fabs, C0, C12, CL, popPK model parameters, Metagenomic feces analyses, feces derived ex vivo drug conversion rates | — |
Countries
Norway
Outcome results
None listed