The goal of this clinical trial is to compare the pharmacodynamics (PD), pharmacokinetics (PK), safety, and tolerability of acetylsalicylic acid powder for oral inhalation (i-ASA) with non-enteric-coated chewable aspirin (C-ASA) in healthy adults by demonstrating bioequivalence. In the first treatment period, subjects will be randomized to receive either a single dose (100 mg) of I-ASA powder via a Dry Powder Inhaler (DPI) OR a single dose (162 mg) of C-ASA tablets. After a washout period, subjects will be crossed over to receive the other treatment in the second treatment period. All subjects will receive both treatments during the study. Each single dose treatment will be followed by up to 24 hours of serial post-dose PK, PD, and safety/tolerability assessments.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
86
powder for oral inhalation via a Dry Powder Inhaler (DPI)
Orally administered
Sinai Hospital
Baltimore, Maryland, United States
Bio-Kinetic Clinical Applications, LLC dba QPS-MO
Springfield, Missouri, United States
Serum thromboxane B2 (TxB2) serum concentration - Area under the effect curve (AUEC) of the % Change from baseline (CFB) in serum TxB2 concentration (TxB2 suppression)
Time frame: 24 hours post-dose
Proportion of subjects achieving significant inhibition of platelet aggregation (<550 Aspirin Reaction Units [ARU])
Time frame: 2 minutes post-dose
TxB2 serum concentration - AUEC of the % CFB in serum TxB2 concentration (TxB2 suppression)
Time frame: 20 minutes post-dose.
TxB2 serum concentration - AUEC of the % CFB in serum TxB2 concentration (TxB2 suppression)
Time frame: 30 minutes post-dose
Time to significant inhibition of platelet aggregation (<550 ARU).
Time frame: assessed up to 24 hours post-dose
Peak plasma concentrations (Cmax) of ASA
PK endpoints
Time frame: pre-dose. minutes post-dose: 2, 5, 10, 20, 30, 45, 60, 120, 180, 360, 480, 720 and 1440
Peak plasma concentrations (Cmax) of SA
PK endpoints
Time frame: pre-dose. minutes post-dose: 2, 5, 10, 20, 30, 45, 60, 120, 180, 360, 480, 720 and 1440
Area under the plasma concentration versus time curve (AUC0-inf)
PK endpoints
Time frame: pre-dose. minutes post-dose: 2, 5, 10, 20, 30, 45, 60, 120, 180, 360, 480, 720 and 1440
Area under the plasma concentration versus time curve (AUC0-t)
PK endpoints
Time frame: pre-dose. minutes post-dose: 2, 5, 10, 20, 30, 45, 60, 120, 180, 360, 480, 720 and 1440
Time to peak plasma concentrations (Tmax) of ASA
PK endpoints
Time frame: pre-dose. minutes post-dose: 2, 5, 10, 20, 30, 45, 60, 120, 180, 360, 480, 720 and 1440
Time to peak plasma concentrations (Tmax) of SA
PK endpoints
Time frame: pre-dose. minutes post-dose: 2, 5, 10, 20, 30, 45, 60, 120, 180, 360, 480, 720 and 1440
Incidence and frequency of Adverse Events.
Time frame: screening through the 7-day to follow-up period
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