The objective of this study is to assess pharmacokinetics (PK) of indacaterol and glycopyrronium, and methodology and practical arrangements for future studies.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
34
Batch A Ultibro Breezhaler 85/43 μg 2 capsules
Batch A Ultibro Breezhaler 85/43 μg 1 capsule
Batch B Ultibro Breezhaler 85/43 μg 2 capsules
CRST Helsinki Oy
Helsinki, Finland
Peak indacaterol concentration in plasma (Cmax)
Time frame: between 0-72 hours after dosing
Peak glycopyrronium concentration in plasma (Cmax)
Time frame: between 0-72 hours after dosing
Indacaterol area under the concentration-time curve from time zero to 30 minutes (AUC30min)
Time frame: 0-30 minutes after dosing
Glycopyrronium area under the concentration-time curve from time zero to 30 minutes (AUC30min)
Time frame: 0-30 minutes after dosing
Indacaterol area under the concentration-time curve from time zero to 72 hours (AUC72h)
Time frame: 0-72 hours after dosing
Glycopyrronium area under the concentration-time curve from time zero to 72 hours (AUC72h)
Time frame: 0-72 hours after dosing
Indacaterol area under the concentration-time curve from time zero to the last sample with a quantifiable concentration (AUCt)
Time frame: 0-18 days after dosing
Glycopyrronium area under the concentration-time curve from time zero to the last sample with a quantifiable concentration (AUCt)
Time frame: 0-18 days after dosing
Indacaterol area under the concentration-time curve from time zero to infinity (AUCinf)
Time frame: 0-18 days after dosing
Glycopyrronium area under the concentration-time curve from time zero to infinity (AUCinf)
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Activated charcoal suspension, granules 50 g / bottle
Time frame: 0-18 days after dosing
Time to reach peak indacaterol concentration in plasma
Time frame: between 0-72 hours after dosing
Time to reach peak glycopyrronium concentration in plasma
Time frame: between 0-72 hours after dosing
Indacaterol terminal elimination half-life (t1/2)
Time frame: 0-18 days after dosing
Glycopyrronium terminal elimination half-life (t1/2)
Time frame: 0-18 days after dosing
Number of adverse events as event counts and subjects counts
Time frame: throughout the study, average 9-12 weeks