Bioequivalence And Food Effect Study Comparing The Commercial Formulation Of Crizotinib To Its Clinical Study Formulations And Commercial Formulation With Or Without Food In Healthy Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

August 31, 2010

Primary Completion Date

November 30, 2010

Study Completion Date

November 30, 2010

Conditions
Healthy
Interventions
DRUG

crizotinib

"Treatment A (Reference 1): a 250 mg single dose of crizotinib administered in a fasted state as 1 × 50-mg IRT and 2 × 100-mg IRTs.~Treatment B (Reference 2): a 250 mg single dose of crizotinib administered in a fasted state as 1 × 50-mg PIC and 2 × 100 mg PICs.~Treatment C (Test for BE, Reference for Food Effect): a 250 mg single dose of crizotinib administered in a fasted state as 1 × 250-mg CIC.~Treatment D (Test High Fat): a 250 mg single dose of crizotinib administered with a high-fat meal as 1 × 250-mg CIC"

Trial Locations (1)

B-1070

Pfizer Investigational Site, Brussels

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY