Conditions: Healthy
Keywords: relative bioavailability pharmacokinetics crizotinib oral liquid formulation formulated capsule
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 22
Healthy volunteers: yes

Brief summary:
This study will be an open-label, randomized, 2-period, 2-treatment, 2-sequence, cross-over single-dose study employing administration of two oral formulations of crizotinib (OLF and FC) in the fasted state to healthy adult subjects. Twenty-two (22) subjects will be enrolled to obtain at least 20 evaluable subjects who complete the study. Each subject will receive two treatments (A and B) with a washout period of at least 14 days between each treatment.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: crizotinib
Intervention descriptions: intervention 1: Each subject will receive 250 mg single oral doses of oral liquid formulation and formulated capsule of crizotinib separated by at least 14 days.

Protocol document: