Comparative Bioavailability of Nilotinib 200 mg Hard Capsules in Healthy Subjects.

You may not qualify if:

• Known hypersensitivity / allergy reaction to the study drug substance or any of the excipients.
• Known rare hereditary problems of galactose intolerance, Lapp-lactase deficiency or glucose-galactose malabsorption.
• Known severe hypersensitivity reaction to any other drug.
• Any medical condition (e.g., gastrointestinal, renal or hepatic, including peptic ulcer, inflammatory bowel disease or pancreatitis) or surgical condition (e.g., cholecystectomy, gastrectomy) that may affect drug pharmacokinetics (absorption, distribution, metabolism or excretion) or subject safety.
• History of relevant hematological disorders.
• History of cardiovascular events.
• History of short QT syndrome, long QT syndrome, or clinically significant cardiac arrythmia.
• Family history of sudden death before 40 years old, short or long QT syndrome.
• Resting heart rate <50 bpm in ECG.
• Baseline QTc interval >450 msec if man or >470 msec if woman, or <350 msec.
• Clinically relevant abnormalities on hemogram.
• Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) above the upper limit of the normal range.
• Estimated renal creatinine clearance (CrCL) below 90 mL/min, based on creatinine clearance calculation by the Cockcroft-Gault formula and normalized to an average surface area of 1.73 m2.
• Serum potassium or magnesium below the lower limit of the normal range.
• Serum lipase above the upper limit of normal range.
• +22 more criteria