To Compare and Evaluate the Oral Bioavailability of Edoxaban 60 mg Film Coated Tablet With That of Lixiana® 60 mg Filmtabletten (Film Coated Tablet) (Edoxaban) in Healthy, Adult, Human Subjects Under Fasting Conditions

Exclusion Criteria

• •History of allergic responses to Edoxaban or other related drugs, or any of its formulation ingredients.
• •Had significant diseases or clinically significant abnormal findings during screening \[medical history, physical examination (clinical examination), laboratory evaluations, ECG recording, gynecological history and examination (including pelvic examination and routine breast examination) (for female volunteers)\].
• •Any disease or condition like diabetes, psychosis or others, which might compromise the haemopoietic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system or any other body system.
• •History or presence of bronchial asthma.
• •Used any hormone replacement therapy within 3 months prior to the first dose of study medication.
• •Used any depot injection or implant of any drug within 3 months prior to the first dose of study medication.
• •Used CYP enzyme inhibitors or inducers within 30 days prior to the first dose of study medication (see https://drug-interactions.medicine.iu.edu/MainTable.aspx).
• •History or evidence of drug dependence or of alcoholism or of moderate alcohol use.
• •History of difficulty with donating blood or difficulty in accessibility of veins.
• •A positive hepatitis screen (includes subtypes B \& C).
• •A positive test result for HIV antibody.
• •Volunteers who had received a known investigational drug within seven elimination half-life of the administered drug prior to the first dose of study medication.
• •Volunteers who had donated blood or loss of blood 50 ml to 100 ml within 30 days or 101 ml to 200 ml within 60 days or \>200 ml within 90 days (excluding volume drawn at screening for this study) prior to first dose of study medication, whichever was greater.
• •History of difficulty in swallowing or of any gastrointestinal disease, which could affect drug absorption.
• •Intolerance to venipuncture
• •Any food allergy, intolerance, restriction or special diet that, in the opinion of the principal investigator or sub-investigator, could contraindicate the volunteer's participation in this study.
• •Institutionalized volunteers.
• •Used any prescribed medications \[including aspirin and other antiplatelet agents, antithrombotic agents, fibrinolytic therapy, nonsteroidal anti-inflammatory drugs (NSAIDs), selective serotonin reuptake inhibitors and serotonin-norepinephrine reuptake inhibitors\] within 14 days prior to the first dose of study medication.
• •Used any OTC products, vitamin and herbal products, etc., within 7 days prior to the first dose of study medication.
• •Used grapefruit and grapefruit containing products within 7 days prior to the first dose of study medication.
• •Ingestion of any caffeine or xanthine products (i.e. coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.), recreational drugs, alcohol or other alcohol containing products within 48 hours prior to the first dose of study medication.
• •Ingestion of any unusual diet, for whatever reason (e.g.: low sodium) for three weeks prior to the first dose of study medication.
• •Volunteer had a platelet count below the lower limit of the normal range during screening.
• •Volunteer had an INR and Prothrombin Time and/or Activated Partial Thromboplastin Time value higher than 1.1 times of the upper limit of normal ranges during screening.
• •Volunteers had SGPT, SGOT and alkaline phosphatase values 1.1 times higher than the upper limit of normal range during screening.
• •Volunteers had serum bilirubin value higher than the upper limit of normal range during screening.
• •History of bleeding disorders or any significant family history of bleeding disorders.
• •History of prosthetic heart valve or history of pulmonary embolism.
• •History of traumatic or repeated epidural or spinal puncture or plan for spinal surgery/spinal procedure or volunteer having any spinal deformity or neurological impairment.
• •Creatinine clearance below 60 mL/min during screening.
• •History or presence of active pathological bleeding.