Irbesartan does not affect the pharmacokinetics of simvastatin in healthy subjects

This open-label, single-dose, crossover study was conducted to assess the e ffect of irbesartan on the pharmacokinetics of total simvastatin acid in 14 healthy subjects. Subjects were randomized to receive one simvastatin 40 m g tablet or one simvastatin 40 mg tablet + one irbesartan 300 mg tablet. Su bjects were crossed over to the other treatment after a 7- to 10-day washou t period. Serum samples were collected at specified times before and over a 24-hour period after dosing. Safety was assessed by monitoring vital signs , laboratory tests, and adverse events. Irbesartan did not exhibit a clinic ally significant effect on the peak serum concentration and larea under the concentration versus time curve to infinity (AUC(0-infinity)) of total sim vastatin acid. The mean AUC(0-infinity) of total simvastatin acid was 74.55 ng x h/mL when simvastatin was given alone and 67.55 ng x h/mL when simvas tatin and irbesartan were given concomitantly. The time to peak serum conce ntration for both treatments was 3 hours. No serious adverse events occurre d during the study, and both agents were well tolerated. In summary, irbesa rtan had no significant effect on the single-dose pharmacokinetics of total simvastatin acid. (C) 2000 the American College of Clinical Pharmacology.