| Budget Amount *help |
¥3,900,000 (Direct Cost: ¥3,000,000、Indirect Cost: ¥900,000)
Fiscal Year 2011: ¥1,300,000 (Direct Cost: ¥1,000,000、Indirect Cost: ¥300,000)
Fiscal Year 2010: ¥2,600,000 (Direct Cost: ¥2,000,000、Indirect Cost: ¥600,000)
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| Research Abstract |
The area under the concentration. time curve(AUC) and/or oral clearance(CL/F) of drugs is a key pharmacokinetic parameter to evaluate drug exposure in patients. In the present study, we conducted a clinical trial to evaluate the pharmacokinetics of bosentan in Japanese pediatric patients. Plasma samples were taken twice at two time points corresponding to the peak concentration(C_<peak>) and trough concentration(C_<trough>) following repetitive oral drug administration to the petients. A large interindividual variability was observed in plasma concentrations of bosentan, and the weight-normalized values of CL/F were correlated negatively with age. We confirmed that the peak-and-trough sampling design is promising for the clinical repeated-dose pharmacokinetic trial for drugs.
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