Exploratory Study of Inhaled Afatinib Dimaleate PK Profile

This is a pilot Phase I open-label randomized single-dose two-period crossover study (in the EDDIS project) evaluating the bioequivalence, pharmacokinetics (PK), safety, and tolerability of inhaled afatinib dimaleate compared with the reference oral afatinib dimaleate in healthy volunteer smokers. The study will enroll healthy adult volunteers smoker to assess the systemic exposure and lung deposition of inhaled afatinib dimaleate. Participants will receive both the test inhaled formulation and the reference oral formulation in separate periods with delayed phase between treatments. Key endpoints include maximum plasma concentration (Cmax), area under the concentration-time curve (AUC), and lung deposition assessed via bronchoalveolar lavage (BAL), frequency of occurrence of side effects and cases of toxicity during the studies

NCT Number	NCT06897735
Lead Sponsor	Petrov, Andrey
Conditions	Lung Cancer, Oral Cancer, Melanoma
Enrollment	4 participants
Start Date	2025-11-09
Primary Completion	2026-05-25 (estimated)
Study Completion	2026-05-25 (estimated)
Updated on ClinicalTrials.gov	2026-06-03