Individual difference in the pharmacokinetics of a drug, pravastatin, in healthy subjects.
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).
Ogawa
Katsutoshi
K
Sekino Research Institute, Ikebukuro 3-28-3, Toshima-ku, Tokyo, 171-0014, Japan.
Hasegawa
Setsuo
S
Udaka
Yuko
Y
Nara
Keinosuke
K
Iwai
Shinichi
S
Oguchi
Katsuji
K
D000328:Adult; D019540:Area Under Curve; D006801:Humans; D008297:Male; D008657:Metabolic Clearance Rate / Q000187:drug effects / Q000502:physiology; D017035:Pravastatin / Q000008:administration & dosage / Q000493:pharmacokinetics*
D017035:Pravastatin