Effect of Steady-State Faldaprevir on Pharmacokinetics of Atorvastatin or Rosuvastatin in Healthy Volunteers: A Prospective Open-Label, Fixed-Sequence Crossover Study
| Autor: | Fenglei, Huang, Kristell, Marzin, Rüdiger, Koenen, Klaus Peter, Kammerer, Natalja, Strelkowa, Mabrouk, Elgadi, Anne-Marie, Quinson, Sebastian, Haertter |
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| Rok vydání: | 2017 |
| Předmět: |
Adult
Male Sulfonamides Aminoisobutyric Acids Cross-Over Studies Serine Proteinase Inhibitors Proline Middle Aged Antiviral Agents Healthy Volunteers Thiazoles Pyrimidines Leucine Atorvastatin Quinolines Humans Drug Interactions Female Hydroxymethylglutaryl-CoA Reductase Inhibitors Rosuvastatin Calcium Oligopeptides |
| Zdroj: | Journal of clinical pharmacology. 57(10) |
| ISSN: | 1552-4604 |
| Popis: | Faldaprevir (FDV) is a potent, orally administered inhibitor of hepatitis C virus protease. It inhibits multiple cytochrome P-450 enzymes and multiple membrane transporters. The objective of this study was to evaluate the effect of steady-state faldaprevir on the pharmacokinetics (PK) of a single dose of atorvastatin or rosuvastatin. In this single-center, open-label, fixed-sequence crossover study, 33 healthy adult male and female volunteers were given either atorvastatin 10 mg (n = 16) or rosuvastatin 10 mg (n = 17) on day 1. Subjects subsequently received 240 mg twice daily of faldaprevir (loading dose) on day 5, followed by 240 mg faldaprevir once daily from day 6 to day 10, with an additional single dose of atorvastatin (10 mg) or rosuvastatin (10 mg) given on day 10. PK samples for the statins were collected on days 1-3 and days 10-12. Concomitant administration with faldaprevir led to approximately 9-fold and 34-fold increases in AUC |
| Databáze: | OpenAIRE |
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