Pharmacokinetic/pharmacodynamic modeling of total lymphocytes and selected subtypes after oral budesonide.

Journal of Pharmacokinetics and Pharmacodynamics
Jeffrey G StarkGuenther Hochhaus

Abstract

In the present pharmacokinetic/pharmacodynamic (PK/PD) evaluation, cortisol, total lymphocytes, and lymphocyte subpopulations were monitored following single oral doses of two oral formulations of 3 mg budesonide (BUD) (Dosage Forms A and B) in order to assess the differential effects that BUD may have on cortisol suppression and the modulation of blood lymphocyte subtypes. On a single occasion, five subjects received one 3 mg capsule of Dosage Form A, four received three capsules of Dosage Form A (single dose of 9 mg), and five received three capsules of Dosage Form B (single dose of 9 mg). Placebo capsules were administered to six subjects in the study. Cortisol concentrations, total lymphocyte counts, and lymphocyte subpopulation counts for the CD3, CD4, CD8, CD19, and CD56/16 were fitted to an in direct PK/PD response model that described the effects of BUD on serum cortisol concentrations as well as the combined effects of BUD and cortisol on total lymphocytes and the CD3, CD4, CD8, CD19, and CD56/16 subtypes. Data were also analyzed using noncompartmental methods. The PK/PD model fitted the data with the exception of data for CD56/16. The IC(50) value for unbound BUD acting on total lymphocytes was 0.276 ng/ml while the I...Continue Reading

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Citations

Jul 16, 2009·Drug Metabolism Reviews·Martin K ChurchMargherita Strolin Benedetti
Sep 2, 2008·Clinical Breast Cancer·Sara M TolaneyHarold J Burstein
Apr 19, 2013·British Journal of Clinical Pharmacology·Patrick BrossardJasper Dingemanse
Feb 24, 2018·Expert Opinion on Drug Safety·Cristina BezzioSimone Saibeni
Apr 29, 2018·Journal of Pharmacokinetics and Pharmacodynamics·Vivaswath S AyyarWilliam J Jusko
Dec 25, 2008·Journal of Pharmacokinetics and Pharmacodynamics·C MeilleG Freyer
Feb 11, 2021·Reviews on Recent Clinical Trials·John J SramekNeal R Cutler

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