Source: Annual Congress 2002 - Asthma and COPD: pharmacology
Disease area: Airway diseases

Abstract

Introduction: Ciclesonide (CIC) is a novel inhaled corticosteroid. Its active principle (CIC-AP) has no oral bioavailability. Methods: In this randomized, open, single dose, two-period crossover study 24 healthy subjects (16 males, 8 females; age 18–43y) inhaled 800μg CIC via metered dose inhalers (MDIs) with two different puff strengths. In one study period they received the dose as 4 puffs of 200μg CIC via the 200μg MDI, in the other period they received the dose as 16 puffs of 50μg CIC via the 50μg MDI. Primary variable of the study was the pharmacokinetic parameter AUC (0,inf) of CIC-AP. Secondary pharmacokinetic variables were Cmax, Cmax/AUC(0,inf), t(1/2) and tmax of CIC-AP. Results: The point estimates and 90%-confidence intervals (CI) for the ratios (4 puffs of 200μg CIC / 16 puffs of 50μg CIC) of the pharmacokinetic characteristics of CIC-AP are shown in the table below.

Pharmacokinetic variable	Point estimate	90%-CI
AUC(0, inf)	1.07	0.99 - 1.16
Cmax	0.99	0.88 - 1.11
T1/2	1.06	1.00 - 1.12
Cmax/AUC(0,inf)	0.92	0.83 - 1.02

All ratios of the pharmacokinetic characteristics were within the bioequivalence range of 0.80-1.25. Both CIC dosing regimen were safe and well tolerated. Conclusion: Based on the results of this study, the two ciclesonide dosing regimen can be regarded as bioequivalent.

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Citations should be made in the following way:
T. D. Bethke, A. Drollmann, B. Hauns, R. Nave, K. Zech, V. W. Steinijans, W. Wurst (Konstanz, Germany). Bioequivalence of two ciclesonide dosing regimen (4 puffs of 200μg vs. 16 puffs of 50μg using an MDI). Eur Respir J 2002; 20: Suppl. 38, 748

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