drugset / Trial / NCT01168934
A Phase 1 Absolute Bioavailability Study For Oral Crizotinib In Healthy Volunteers
RandomizedParallel-groupOpen-label
Summary
This study will be an open-label, randomized, 2-period, 2-treatment, 2-sequence, cross-over single-dose study to test the absolute bioavailability of oral crizotinib formulation to IV formulation in healthy adult volunteers. Fourteen (14) subjects will be enrolled to obtain at least 12 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.
Timeline
- Start
- 2010-08
- Primary completion
- 2010-09
- Completion
- 2010-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Crizotinib | Small molecule | 50 mg | Intravenous |
| Subject | Crizotinib | Small molecule | 250 mg | Intravenous |
Indications
No indication recorded.