The purpose of this study is to test the body's response to several doses of two different inhalation products in healthy volunteers.
Healthy subjects will be enrolled and will receive 2, 6, and 12 inhalations from both the test and reference pMDI products according to a six-period cross-over design. Electrocardiograms (ECGs) and plasma potassium and glucose levels will be measured pre-dose and over 6 hours post-dose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
52
A, D 2 puffs; B, E 6 puffs; C, F 12 puffs
A, D 2 puffs; B, E 6 puffs; C, F 12 puffs
Quotient Clinical Ltd
Ruddington, Nottingham, United Kingdom
Relative Potency Max Heart Rate
Selection of steepest part of dose response curve for Relative Potency: 6 and 12 inhalation dose pairs. Slope of B and C line compared with slope of E and F to obtain relative potency value. Two inhalation dose not utilized as not on steepest part of curve.
Time frame: Baseline, up to 6 hrs
Relative Potency QTcB Interval
Selection of steepest part of dose response curve for Relative Potency: 2 and 6 inhalation dose pairs. Slope of A and B line compared with slope of D and E to obtain relative potency value. Twelve inhalation dose not utilized as not on steepest part of curve.
Time frame: Baseline up to 6 hrs
Max Heart Rate
max heart rate at the 2, 6, or 12 inhalations dose, assessed at multiple times over 6 hours
Time frame: Baseline through 6 hours
Plasma Potassium Level
maximum plasma levels of potassium at 2, 6 or 12 inhalations dose inhalations dose, assessed a multiple times over 6 hours.
Time frame: baseline through 6 hours
Max Plasma Glucose Level
maximum levels of glucose at the 2, 6 or 12 inhalations dose, assessed at multiple times over 6 hours.
Time frame: baseline through 6 hours
Max QTcB
For each dose, the 95% CIs for the mean difference for the test product versus the reference product were calculated.
Time frame: Baseline through 6 hours
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.