Pharmacokinetic characteristics of fluticasone, salmeterol and tiotropium after concurrent inhalation

Translational and Clinical Pharmacology
Jung SunwooIn-Jin Jang

Abstract

Chronic obstructive pulmonary disease (COPD) is a type of progressive, obstructive lung disease characterized by long-term poor airflow. The symptoms of COPD may be relieved and its progression delayed by fluticasone (FTS), salmeterol (SM), and tiotropium (TTP). The aim of this study is to investigate pharmacokinetic (PK) characteristics of inhaled FTS, SM, and TTP after co-administration. An open-label, single-arm, three-period, simple ascending dose study was conducted in 10 healthy male subjects. A single dose of FTS/SM (250/50 µg) and TTP (18 µg) were concomitantly inhaled in period 1, and the dose of each drug was escalated to two- and three-fold in periods 2 and 3, respectively, with a 2-week washout between periods. Activated charcoal was co-administered before and after inhalation to block gastrointestinal absorption. Blood samples for PK analysis were collected up to 24 hours. PK parameters were obtained by non-compartmental analysis. FTS, SM, and TTP rapidly reached maximum plasma concentration after inhalation (0.08-3.00 h, 0.03-0.10 h and 0.03-0.10 h, respectively) and were eliminated with mean half-lives of 9.29-10.44 h, 6.09-12.39 h and 0.25-47.42 h, respectively. PK assessment of the lowest dose of TTP was limite...Continue Reading

References

Mar 20, 1998·Journal of Clinical Pharmacology·G HochhausR J Gonzalez-Rothi
Jan 6, 2001·Pharmaceutical Research·B P SmithS T Forgue
Feb 5, 2002·Clinical Pharmacokinetics·Mario CazzolaMaria Gabriella Matera
Apr 12, 2003·British Journal of Clinical Pharmacology·S D SinghA A Woodcock
Feb 21, 2007·Annals of Internal Medicine·Shawn D AaronUNKNOWN Canadian Thoracic Society/Canadian Respiratory Clinical Research Consortium
Oct 7, 2011·Respiratory Medicine·Ki Suck JungUNKNOWN Korea Chronic Obstructive Pulmonary Disease study group

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Clinical Trials Mentioned

NCT02441114

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SAS
Phoenix® Win - Nonlin®

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