Study to Compare the Pharmacodynamics and Pharmacokinetics of Acetylsalicylic Acid Powder for Oral Inhalation With Non-enteric-coated Chewable Aspirin in Healthy Adults.

Inclusion criteria

• Male or female, ≥18 and ≤55 years of age, with BMI >18.5 and <32.0 kg/m2 and body weight ≥50.0 kg for males and ≥45.0 kg for females.
• Healthy as defined by:

• the absence of clinically significant illness and surgery within 4 weeks prior to dosing.
• the absence of clinically significant history of neurological, endocrine, cardiovascular, pulmonary, respiratory, hematological (e.g., thrombocytopenia, neutropenia, bleeding disorders), immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
• Female subjects of non-childbearing potential must be:

• post-menopausal OR
• surgically sterile at least 3 months prior to dosing.
• Sexually active female subjects of childbearing potential must be willing to use an acceptable contraceptive method throughout the study as defined in the protocol.
• Current non-smoker: no use of tobacco or nicotine products, including any smoking cessation nicotine-containing products (i.e., nicotine replacement therapy [patch, spray, inhaler, gum, lozenge, bupropion SR, clonidine and nortriptyline], e-cigarettes, etc.) for at least 3 months prior to screening.
• Agrees to refrain from alcohol consumption for at least 48 hours prior to admission and 48 hours after drug administration of each period.
• Able to understand the study procedures and provide signed informed consent to participate in the study.

Exclusion criteria

• Any clinically significant abnormal finding at physical examination at screening.
• Positive serology test results for HBsAg, HCV antibody, or HIV antigen and antibody, at screening.
• Positive pregnancy test or lactating female subject.
• Positive urine drug screen, urine cotinine test, or alcohol breath test.
• Known allergic reactions, hypersensitivity or contraindications to aspirin (ASA), ibuprofen, other NSAIDs, or other related drugs, or to any excipient in the formulation.
• Known lack of response (lack of effect) to aspirin in the past.
• Clinically significant x-ray, ECG abnormalities or vital signs abnormalities at screening.
• Clinically significant abnormal laboratory parameters including:

• Hematocrit value ≤ 32%;
• Platelet count <142,000 or > 450,000 platelets per µL;
• ALT ≥ 3 x ULN;
• AST ≥ 3 x ULN.
• Subject with abnormal lung function defined by spirometric testing such that: the post bronchodilator FEV1 < 80% of predicted normal value OR FEV1/FVC ratio < 0.70.
• Subject with current asthma defined as post-bronchodilator FEV1 > 12% increase AND > 200 ml absolute increase from pre-bronchodilator values.

Other protocol-defined I/E criteria that apply.