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A Single-center, Randomized, Open-label, Three-period Crossover Study to Investigate the Bioequivalence of Alpelisib Granule and Film-coated Tablet Formulation, and the Food Effect of Alpelisib Granule Formulation in Adult Healthy Volunteers

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Trial Profile

A Single-center, Randomized, Open-label, Three-period Crossover Study to Investigate the Bioequivalence of Alpelisib Granule and Film-coated Tablet Formulation, and the Food Effect of Alpelisib Granule Formulation in Adult Healthy Volunteers

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 30 Dec 2022

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At a glance

  • Drugs Alpelisib (Primary) ; Alpelisib
  • Indications Breast cancer; Gastric cancer; Gastrointestinal stromal tumours; Growth disorders; Head and neck cancer; Multiple myeloma; Non-small cell lung cancer; Oesophageal cancer; Ovarian cancer; Pancreatic cancer; Rectal cancer; Solid tumours; Uveal melanoma
  • Focus Pharmacokinetics
  • Sponsors Novartis Pharmaceuticals

Most Recent Events

  • 27 Dec 2022 Status changed from active, no longer recruiting to completed.
  • 24 Oct 2022 Status changed from recruiting to active, no longer recruiting.
  • 29 Jun 2022 Planned End Date changed from 31 May 2022 to 2 Nov 2022.

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