Pomelo enhances cyclosporine bioavailability in healthy male Thai volunteers.
J Clin Pharmacol
; 55(4): 377-83, 2015 Apr.
Article
en En
| MEDLINE
| ID: mdl-25408261
ABSTRACT
The aim of this study was to investigate the effect of pomelo pulp on the pharmacokinetics of cyclosporine in healthy male Thai volunteers. The study design was an open-label, randomized, single dose, crossover study with a 2-week washout period. A single oral dose of 2 × 100 mg cyclosporine was administered with 200 mL of water. Each subject received 250 g of pomelo pulp or 250 mL of water 1 hour before drug administration and once again 10 minutes following drug administration. Blood samples were collected over a 24 hour period. The point estimates (90% confidence intervals) of the test/control ratio using logarithmic transformed data for the area under the curve (AUC) for blood concentration from time 0 to infinity (AUC(0- ∞)) and the observed maximum concentration (C(max)) were 128.8% (120.6-137.6) and 136.1% (126.0-146.8), respectively. These 90% confidence intervals were higher than the accepted bioequivalence range defined by the European Medicines Agency guidelines for narrow therapeutic index drugs (90%-111% for AUC and 80%-125% for C(max)). However, the apparent terminal half-life (t(1/2)) was not significantly different. In conclusion, co-administration of cyclosporine and pomelo pulp increased the relative bioavailability of cyclosporine.
Palabras clave
Texto completo:
1
Bases de datos:
MEDLINE
Asunto principal:
Citrus
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Ciclosporina
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Interacciones de Hierba-Droga
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Pueblo Asiatico
Tipo de estudio:
Clinical_trials
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Guideline
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Prognostic_studies
Idioma:
En
Revista:
J Clin Pharmacol
Año:
2015
Tipo del documento:
Article
País de afiliación:
Tailandia