Open-label, Randomized, 3-period, 3-treatment Crossover, Bioequivalence Study Comparing Dasatinib (BMS-354825) Liquid Formulation and the Dispersed Tablet Formulation Relative to the Reference Tablet Formulation in Health Subjects
Inclusion Criteria:
- Healthy subjects as determined by no clinically significant deviation from normal in
medical history, physical examination, ECGs, and clinical laboratory determinations
- Body mass index (BMI) of 18 to 32 kg/m2 , inclusive
- Adults aged 18 to 55 years
Exclusion Criteria:
- Any significant acute or chronic medical illness
- Current or recent (within 3 months of study drug administration) gastrointestinal
disease that may impact drug absorption and may affect PK of the study drugs or any
gastro (GI) surgery that may impact drug absorption
- Blood transfusion within 4 weeks of study drug administration
- Donation of >400mL of blood within 8 weeks prior to study dosing or donation of
plasma within 4 weeks prior to study dosing
- Inability to tolerate oral medication
- Inability to tolerate orange juice
- Inability to undergo venipuncture and/or tolerate venous access
- Any major surgery within 4 weeks of study drug administration
- Use of tobacco or nicotine-containing products within 6 months prior to check-in, or
positive nicotine test at screening and/or check-in
- Subjects who drink more than 3 cups of coffee or other caffeine containing products a
day, or 5 cups of tea a day
- Recent (within 6 months of study drug administration) drug or alcohol abuse
- Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or Human
immunodeficiency virus (HIV-1), -2 antibody
- History of any significant drug allergy or asthma
- Women who are pregnant or breastfeeding and/or unwilling or unable to use an
acceptable method to avoid pregnancy for the entire study period