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A Phase I Pilot Study to Evaluate the Bioequivalence, Pharmacokinetics, and Safety of Inhaled Afatinib Dimaleate Compared to the Reference Oral Afatinib Dimaleate in Healthy Smoking Volunteers

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Trial Profile

A Phase I Pilot Study to Evaluate the Bioequivalence, Pharmacokinetics, and Safety of Inhaled Afatinib Dimaleate Compared to the Reference Oral Afatinib Dimaleate in Healthy Smoking Volunteers

Status: Not yet recruiting
Phase of Trial: Phase I

Latest Information Update: 21 Nov 2025

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At a glance

  • Drugs Afatinib (Primary) ; Afatinib (Primary)
  • Indications Breast cancer; Chordoma; Glioma; Head and neck cancer; HER2 negative breast cancer; Neuroectodermal tumours; Non-small cell lung cancer; Oesophageal cancer; Rhabdomyosarcoma; Urogenital cancer
  • Focus Pharmacokinetics
  • Acronyms EDDIS-a1

Most Recent Events

  • 18 Nov 2025 Planned End Date changed from 25 Mar 2026 to 7 May 2026
  • 18 Nov 2025 Planned primary completion date changed from 25 Dec 2025 to 25 Mar 2026.
  • 18 Nov 2025 Planned initiation date changed from 25 Aug 2025 to 9 Nov 2025.

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