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:
2025-12-24 @ 10:03 PM
Ignite Modification Date:
2025-12-24 @ 10:03 PM
NCT ID:
NCT06897735
Eligibility Criteria:
Inclusion Criteria:
* Healthy male and female volunteers aged 21 to 55 years
* Body mass index (BMI) from 18.5 to 30.0 kg/m²
* Smokers or people who use e-cigarettes or vapes
* No history of serious lung disease or respiratory disorders
* No history of EGFR-targeted therapy or chemotherapy
* Ability to give informed consent and comply with study procedures
Exclusion Criteria:
* Pregnancy or lactation. (for female participants - 2 negative tests 10 days and 3 days before the start of the study)
* Significant cardiovascular, hepatic, renal or neurological disorders. (ECG 30 days or earlier before the start of the study)
* Recent use of any study drug (within 30 days) or prescription drugs that may affect the metabolism of afatinib
* Known hypersensitivity to afatinib, its salts or derivatives of afatinib or related compounds
* Рarticipation in other studies
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
55 Years
Study:
NCT06897735
Study Brief:
Protocol Section:
NCT06897735