Effect of Breakfast on the Exposure of the Once-Daily Tacrolimus Formulation in Stable Kidney Transplant Recipients
| Autor: | Frank Stifft, Johannes P. van Hooff, Maarten H. L. Christiaans, Nasrullah Undre |
|---|---|
| Přispěvatelé: | Interne Geneeskunde, MUMC+: MA Nefrologie (9), RS: NUTRIM - R3 - Chronic inflammatory disease and wasting |
| Rok vydání: | 2016 |
| Předmět: |
Adult
Male medicine.medical_specialty immunosupression Chemistry Pharmaceutical Cmax Biological Availability food interaction 030230 surgery Pharmacology 030226 pharmacology & pharmacy Gastroenterology Drug Administration Schedule Tacrolimus 03 medical and health sciences 0302 clinical medicine Pharmacokinetics Internal medicine medicine Ingestion Humans Pharmacology (medical) Kidney transplantation Breakfast Cross-Over Studies business.industry Middle Aged medicine.disease Crossover study Kidney Transplantation Bioavailability Area Under Curve Trough level Female business pharmacokinetics Immunosuppressive Agents |
| Zdroj: | Therapeutic Drug Monitoring, 38(4), 456-462. LIPPINCOTT WILLIAMS & WILKINS |
| ISSN: | 1536-3694 0163-4356 |
| Popis: | Background:The once-daily Tacrolimus formulation (Tac ONCE-DAILY) has to be taken on an empty stomach. This is inconvenient for patients and may hamper compliance. The influence of food intake on the exposure of Tac ONCE-DAILY is unknown in transplant recipients. We compared the pharmacokinetics (PKs) of Tac ONCE-DAILY in stable kidney transplant recipients under fasted and fed conditions.Methods:In an open-label, single-center, cross-over PK study, 27 stable kidney white transplant recipients (17 male, 10 female) treated with Tac ONCE-DAILY under fasted conditions were enrolled. Two 10-point 24-hour blood concentration time profiles [area under the blood concentration time curve from time 0 to 24 hours (AUC(0-24))] were collected under steady state conditions. The primary objective was to investigate the effect of food on the PKs and relative bioavailability of Tac ONCE-DAILY.Results:Twenty-seven stable renal transplant patients provided 1 AUC(0-24) under fasted and fed conditions, respectively. AUC(0-24), C-24, and Cmax, were lower in the fed state and Tmax was 1 hour postponed. The 90% confidence interval ratio (fed: fasted) for AUC(0-24) was 0.81-0.91 and for C-24 0.82-0.92 (both P |
| Databáze: | OpenAIRE |
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