U.S., March 28 -- ClinicalTrials.gov registry received information related to the study (NCT06897735) titled 'Exploratory Study of Inhaled Afatinib Dimaleate PK Profile' on March 02.
Brief Summary: 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...