Bioequivalence test of 2 alpelisib formulations including food effect.

• Research type

  Research Study

• Full title

  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.

• IRAS ID

  300838

• Contact name

  Patrick Winiger

• Contact email

  patrick.winiger@celerion.com

• Sponsor organisation

  Novartis Pharmaceuticals Corporation, USA

• Eudract number

  2021-000371-36

• Clinicaltrials.gov Identifier

  NCT05195892

• Duration of Study in the UK

  0 years, 4 months, 13 days

• Research summary

  The study is designed to investigate the rate and extent of absorption of two different formulations (tablet vs. granule) of a drug (Alpelisib) and the effect of food on the granule formulation.

• REC name

  HSC REC B

• REC reference

  21/NI/0097

• Date of REC Opinion

  17 Jun 2021

• REC opinion

  Favourable Opinion