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The steady‐state disposition of indinavir is not altered by the concomitant administration of clarithromycin
Author(s) -
Boruchoff Susan E.,
Sturgill Marc G.,
Grasing Kenneth W.,
Seibold James R.,
McCrea Jackie,
Winchell Gregory A.,
Kusma Sandra E.,
Deutsch Paul J.
Publication year - 2000
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1067/mcp.2000.105151
Subject(s) - indinavir , clarithromycin , pharmacokinetics , cmax , crossover study , placebo , pharmacology , bioequivalence , area under the curve , oral administration , medicine , chemistry , sida , human immunodeficiency virus (hiv) , immunology , pathology , alternative medicine , viral disease , helicobacter pylori
Study Objectives To evaluate the safety and potential pharmacokinetic interaction between indinavir and clarithromycin. Study Methods In a randomized, three‐period, crossover fashion, 12 healthy adults received the following for 1 week: 800 mg oral indinavir sulfate every 8 hours with placebo, 500 mg oral clarithromycin every 12 hours with placebo, and indinavir sulfate with clarithromycin. Plasma indinavir, clarithromycin, and 14‐hydroxyclarithromycin concentrations were determined after the last dose in each treatment period. Results Administration of indinavir sulfate with clarithromycin caused a statistically significant increase in four pharmacokinetic parameters: a 58% increase in plasma indinavir concentrations at 8 hours (P = .029), a 47% increase in values for clarithromycin area under the plasma concentration versus time curve from time zero to the last measured concentration [AUC(0‐12h); P = .0002], and 49% and 48% decreases in 14‐hydroxyclarithromycin AUC(0‐12h) and maximum plasma concentration (C max ) values, respectively (P = .0001 and P = .0001). These effects are not considered to be clinically significant in view of the insignificant effects on the values for indinavir area under the plasma concentration versus time curve from time zero to the last measured concentration [AUC(0‐8h)] and C max , as well as the safety profile of clarithromycin. Conclusions The combination of indinavir sulfate and clarithromycin is generally well tolerated and can be coadministered without dose adjustment. (Clin Pharmacol Ther 2000;67:351‐9.) Clinical Pharmacology & Therapeutics (2000) 67 , 351–359; doi: 10.1067/mcp.2000.105151

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