NCT05195892View on ClinicalTrials.gov

Investigate Bioequivalence of Alpelisib Granule and Film-coated Tablet Formulation and the Food Effect of Alpelisib Granule Formulation in Adult Healthy Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

33

Participants

Timeline

Start Date

February 3, 2022

Primary Completion Date

November 9, 2022

Study Completion Date

November 9, 2022

Conditions
Healthy Volunteers
Interventions
DRUG

Treatment A

Single oral dose of alpelisib film-coated tablet at 50 mg in fed state

DRUG

Treatment B

Single oral dose of alpelisib granule at 50 mg in fed state

DRUG

Treatment C

Single oral dose of alpelisib granule at 50 mg in fasted state

Trial Locations (1)

BT9 6AD

Novartis Investigative Site, Belfast

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY