Individual difference in the pharmacokinetics of a drug, pravastatin, in healthy subjects.
J Clin Pharmacol
; 43(11): 1268-73, 2003 Nov.
Article
en En
| MEDLINE
| ID: mdl-14551181
ABSTRACT
The purpose of this investigation was to determine whether there were individual pharmacokinetic differences of a drug, pravastatin. Furthermore, the percentage of subjects who showed pharmacokinetic differences was determined. A single oral dose of pravastatin 10 mg was administered to 84 Japanese healthy male subjects. Serum concentrations of pravastatin were measured for 8 hours postdose. Area under the concentration-time curve (AUC) and peak concentration (Cmax) were determined as primary evaluation parameters. An outlier was defined as follows Outlier 1 < Q1 - (Q3 - Q1) x 1.5 or Q3+(Q3-Q1) x 1.5 < Outlier 1, Outlier 2 < Q1 - (Q3 - Q1) x 3 or Q3+ (Q3-Q1) x 3 < Outlier 2. Subjects who were outliers were regarded as having an individual difference in pharmacokinetic behavior. In AUC and Cmax, 4 of 84 subjects (4.8%) were higher outliers. Of these 4 subjects, 2 were high outliers in both AUC and Cmax. No subjects were low outliers. It was concluded that a significant individual difference in the pharmacokinetics of pravastatin was observed in 4.8% of the subjects (4/84).
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Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Pravastatina
Tipo de estudio:
Prognostic_studies
Límite:
Adult
/
Humans
/
Male
Idioma:
En
Revista:
J Clin Pharmacol
Año:
2003
Tipo del documento:
Article
País de afiliación:
Japón