Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-25 @ 2:20 AM
NCT ID:
NCT05625334
Eligibility Criteria:
Inclusion Criteria:
1. 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.
2. Healthy as defined by:
1. the absence of clinically significant illness and surgery within 4 weeks prior to dosing.
2. 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.
3. Female subjects of non-childbearing potential must be:
1. post-menopausal OR
2. surgically sterile at least 3 months prior to dosing.
4. Sexually active female subjects of childbearing potential must be willing to use an acceptable contraceptive method throughout the study as defined in the protocol.
5. 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.
6. Agrees to refrain from alcohol consumption for at least 48 hours prior to admission and 48 hours after drug administration of each period.
7. Able to understand the study procedures and provide signed informed consent to participate in the study.
Exclusion Criteria:
1. Any clinically significant abnormal finding at physical examination at screening.
2. Positive serology test results for HBsAg, HCV antibody, or HIV antigen and antibody, at screening.
3. Positive pregnancy test or lactating female subject.
4. Positive urine drug screen, urine cotinine test, or alcohol breath test.
5. Known allergic reactions, hypersensitivity or contraindications to aspirin (ASA), ibuprofen, other NSAIDs, or other related drugs, or to any excipient in the formulation.
6. Known lack of response (lack of effect) to aspirin in the past.
7. Clinically significant x-ray, ECG abnormalities or vital signs abnormalities at screening.
8. Clinically significant abnormal laboratory parameters including:
1. Hematocrit value ≤ 32%;
2. Platelet count \<142,000 or \> 450,000 platelets per µL;
3. ALT ≥ 3 x ULN;
4. AST ≥ 3 x ULN.
9. 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.
10. 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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT05625334
Study Brief:
Protocol Section:
NCT05625334