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Individual Difference in the Pharmacokinetics of a Drug, Pravastatin, in Healthy Subjects

From the Sekino Research Institute, Tokyo, Japan (K. Ogawa, Dr. Hasegawa) and the Department of Pharmacology, Showa University School of Medicine, Tokyo, Japan (K. Ogawa, Y. Udaka, Dr. Nara, Dr. Iwai, Dr. Oguchi).

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 (C_max) 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 C_max, 4 of 84 subjects (4.8%) were higher outliers. Of these 4 subjects, 2 were high outliers in both AUC and C_max. 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).

Key Words: Individual difference • pharmacokinetics • pravastatin • healthy subjects

Address for reprints: Katsutoshi Ogawa, Sekino Research Institute, Ikebukuro 3-28-3, Toshima-ku, Tokyo, 171-0014, Japan.

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