Bioequivalence of Apixaban 5 mg Film-Coated Tablets in Healthy Subjects Under Fasting Conditions.

You may not qualify if:

• 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 participant safety.
• History of drug or alcohol abuse.
• Known hereditary galactose intolerance, total lactase deficiency or glucosegalactose malabsorption.
• History of significant bleeding episode (i.e., symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome, and/or bleeding causing a fall in hemoglobin levels of 2 g/dL or greater, or leading to a transfusion of ≥2 U of whole blood or red blood cells).
• History of significant coagulation disorders (e.g., hemophilia, Von Willebrand disease, clotting factor deficiencies, hypercoagulable states and deep venous thrombosis).
• History of hepatic disease associated with coagulopathy and bleeding risk.
• Presence of clinically significant active bleeding.
• Presence of any lesion or condition considered to be a significant risk for major bleeding, as assessed by the Investigator.
• Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) above the upper limit of the normal range.
• Estimated renal creatinine clearance (CLCr) below the lower limit of normal range, based on creatinine clearance calculation by the Cockcroft-Gault formula and normalized to an average body surface area of 1.73 m2.
• Positive result in drugs-of-abuse or ethanol tests.
• Use of a depot injection or an implant of any drug (except for contraceptives) within the previous 6 months (180 days).
• Average weekly alcohol consumption of >14 units for males and >7 units for females within the previous 6 months (180 days).
• +19 more criteria