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A Randomized, Open-Label, Single Dose, Cross-Over Study To Investigate The Bioequivalence Of Three RO5424802 Test Formulations Versus A Reference Formulation Following Oral Administration In Healthy Subjects

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Trial Profile

A Randomized, Open-Label, Single Dose, Cross-Over Study To Investigate The Bioequivalence Of Three RO5424802 Test Formulations Versus A Reference Formulation Following Oral Administration In Healthy Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 15 Dec 2023

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At a glance

  • Drugs Alectinib (Primary)
  • Indications Non-small cell lung cancer
  • Focus Pharmacokinetics
  • Sponsors Roche

Most Recent Events

  • 12 Mar 2016 Primary endpoint has not been met. (Ratio of geometric means (GMRs) for Cmax, AUClast, and AUC for 12.5% and 3% SLS formulation), as per results presented at the 117th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics.
  • 12 Mar 2016 Primary endpoint has been met. (Ratio of geometric means (GMRs) for Cmax, AUClast, and AUC for 25% SLS formulation), as per results presented at the 117th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics.
  • 12 Mar 2016 Results presented at the 117th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics

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