Abstract
Background: No pharmacokinetic studies of salmeterol HFA pMDI with a spacer device have been published. In this study comparative bioavailability of two salmeterol HFA pMDI formulations administered through a spacer device was evaluated using pharmacokinetic endpoints.
Aim: To compare the rate and extent of absorption of the test product Salmeterol xinafoate HFA pMDI (Cipla Ltd.) with that of the reference product Serevent Evohaler (supplied by Allen & Hanburys, UK), both administered using a spacer.
Methods: This was a balanced, open label, randomised, two-period, single dose, crossover comparative bioavailability study in 24 healthy subjects. Eligible subjects were randomly assigned to receive a single dose of 100μg of both test and reference product administered with a spacer in a crossover manner on two treatment days. The two treatment days were separated with a washout period of 1 week. The blood samples were collected upto 24 hrs. Safety assessments including ECG, tremor assessment, serum potassium and blood glucose were also done at predefined time points. The primary endpoints were Cmax and AUC0-t.
Results: The plasma concentration–time profile of the test product (T) was similar in shape to that of the reference product (R). The T/R ratio of the geometric mean for Cmax and AUC0-t was 94.54 (90% CI 87.11-102.61) and 90.68 (90% CI 83.87–98.03) respectively. The CI limits for Cmax and AUC0-t was well within the bioequivalence range of 80 – 125%.
Conclusion: The bioavailability of the two HFA formulations of salmeterol when administered with a spacer was comparable and both the treatments were safe and well tolerated.
- © 2011 ERS