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Search / Trial NCT06897735

Exploratory Study of Inhaled Afatinib Dimaleate PK Profile

Launched by PETROV, ANDREY · Mar 26, 2025

Trial Information

Current as of April 23, 2025

Not yet recruiting

Keywords

Afatinib Dimaleate Bibw2992 Dimaleate Giotrif Gilotrif

ClinConnect Summary

Participants will receive either a single dose of inhaled afatinib dimaleate or a 40 mg oral dose of afatinib dimaleate in a randomized sequence, with a 7-day washout period between treatments.

The inhaled formulation of afatinib dimaleate is administered via a single-use, maintenance-free ultrasonic nebulizer (by SWITZERLAND TEAM) that generates aerosol particles of a defined size, ensuring predictable bioavailability and targeted alveolar deposition. Each inhalation session consists of a predefined number of physiological breaths, facilitating efficient drug uptake into the lungs at ther...

Gender

ALL

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

About Petrov, Andrey

Petrov, Andrey is a dedicated clinical trial sponsor focused on advancing medical research and innovation. With a commitment to ethical standards and patient safety, the organization specializes in designing and managing clinical trials across various therapeutic areas. Leveraging a robust network of healthcare professionals and research institutions, Petrov, Andrey aims to facilitate the development of new therapies that address unmet medical needs. The sponsor is recognized for its collaborative approach and rigorous adherence to regulatory guidelines, ensuring that clinical studies are conducted with the utmost integrity and scientific rigor.

Locations

Auckland, , New Zealand

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported