The study is aimed to assess the dose proportional total systemic exposure (when the administration is without the activated charcoal) to B17MP (active metabolite of BDP) and its lung bioavailability (when the administration is with the activated charcoal) after single inhalation of CHF 1535 NEXThaler DPI at two dose strengths. At the same time, the study will assess if the lung deposition and the total systemic exposure to Formoterol is affected by increasing doses of BDP.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Active comparator
Placebo comparator
The Medicine Evaluation Unit
Manchester, United Kingdom
Formoterol AUC0-t and B17MP AUC0-t
Time frame: from predose until 12 hr post dose
BDP pharmacokinetic (PK) parameters
The following parameters will be evaluated: AUC0-t, AUC0-12h, AUC0-inf, Cmax, tmax, t1/2
Time frame: from predose until 12 hr post dose
Other PK parameter of B17MP and formoterol
the following pharmacokinetic parameters will be evaluated: AUC0-12, AUCinf, Cmax, tmax, t1/2
Time frame: from predose until 12 hours postdose
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