J Clin Pharmacol
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PHARMACOKINETICS

Single- and Multiple-Dose Pharmacokinetics of Pioglitazone in Adolescents With Type 2 Diabetes

Michael L. Christensen, PharmD, Bernd Meibohm, PhD, Edmund V. Capparelli, PharmD, Pedro Velasquez-Mieyer, MD, George A. Burghen, MD and William V. Tamborlane, MD

From the Pediatric Pharmacology Research Units, the University of Tennessee and LeBonheur Children's Medical Center, Memphis, (Dr Christensen, Dr Meibohm, Dr Velasquez-Mieyer, Dr Burghen); the University of California, San Diego (Dr Capparelli); and Yale University, New Haven, Connecticut (Dr Tamborlane).

This study assessed the single- and multiple-dose pharmacokinetics of 3 doses (15 mg, 30 mg, and 45 mg) of pioglitazone in 36 adolescents with type 2 diabetes. Blood samples were obtained over a 48-hour interval after the first dose (day 1) and over a 72-hour interval after the last dose (day 15) of pioglitazone and were assayed for pioglitazone and active metabolites (M-III and M-IV). Pioglitazone systemic exposure increased dose dependently but was less than dose proportional during multiple dosing. The median peak pioglitazone concentration occurred at 2 hours. The mean half-life was 8 to 9 hours for pioglitazone and 24 to 32 hours for M-III and M-IV, with similar values at each dose level. During multiple dosing, accumulation for pioglitazone was negligible, but it reached 2.5- to 3.0-fold for M-III and M-IV. The sustained total serum concentration of active compounds during multiple dosing provides the basis for once-daily dose administration of pioglitazone in adolescents.

Key Words: Pioglitazone • pharmacokinetics • type 2 diabetes • adolescents

Address for reprints: Michael L. Christensen, PharmD, University of Tennessee, 50 North Dunlap, Room 306, Memphis, TN 38103.






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