Bioequivalence of Eltrombopag 75 mg Film-Coated Tablets in Healthy Subjects Under Fasting Conditions

You may not qualify if:

• Eastern-/Southeastern-Asian (i.e., Chinese, Japanese, Taiwanese or Korean) subjects.
• Known hypersensitivity/allergy reaction to the study drug substance or any of the excipients.
• 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’s safety.
• History of splenectomy.
• History of liver impairment.
• History of thromboembolic event.
• History of risk factors for thromboembolic events (e.g., inherited hypercoagulable disorders and auto-immune disorders with hypercoagulable states).
• History of platelets disorders.
• History of cataracts.
• Platelets levels below the lower limit of the normal range or above 400 x 109/L.
• Serum transaminases alanine aminotransferase (ALT) or aspartate aminotransferase (AST) outside 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.
• Total bilirubin above the ULN.
• Resting heart rate <50 bpm in ECG.
• +20 more criteria