This study will be carried out in healthy volunteers with the primary objective to evaluate the pharmacokinetic interaction between Glyco and Formoterol administered using a pressurised metered dose inhaler (pMDI).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
44
glycopyrrolate pMDI + formoterol pMDI
glycopyrrolate pMDI
formoterol pMDI
Clinical Pharmacology Unit - SGS Life Science Services
Antwerp, Lange Beeldekensstraat 267, Belgium
Pharmacokinetics: formoterol and glyco AUC0-t
Area under the plasma concentration curve observed from administration up to the last measurable concentration.
Time frame: from pre-dose to 32 hours after administration
Pharmacokinetics: formoterol and glyco Cmax
Maximum plasma concentration
Time frame: from pre-dose to 32 hours after administration
Additional pharmacokinetic variables
Plasma Glyco AUC0-30min, AUC0-32h, AUC0-inf, tmax and t1/2 - Plasma Formoterol AUC0-30min, AUC0-24h, AUC0-inf, tmax and t1/2.
Time frame: from pre-dose to 32 hours post dose
Serum potassium
Serum potassium Cmin, tmin and AUC0-24h
Time frame: From pre-dose to 24 hours after administration
Plasma glucose
Plasma glucose Cmax, tmax and AUC0-24h
Time frame: from pre-dose to 24 hours after administration
Lung function
FEV1 in order to assess potential occurrence of paradoxical bronchospasm
Time frame: from pre-dose to 1 hour after administration
Vital signs
heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP).
Time frame: from pre-dose to 24 hours after administration
ECG
12-lead ECG parameters: HR, RR, PR, QRS, QT, QTcB, QTcF
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placebo pMDI
Time frame: from pre-dose to 24 hours after administration