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

Korábbi kezelés

• 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.
• 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.
• 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.

Más betegség

• History of allergic responses to Edoxaban or other related drugs, or any of its formulation ingredients.
• 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 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.
• History of difficulty in swallowing or of any gastrointestinal disease, which could affect drug absorption.
• 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.
• 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.
• History or presence of active pathological bleeding.

Laborértékek

• 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)].
• 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.
• Creatinine clearance below 60 mL/min during screening.

Egyéb

• History or presence of bronchial asthma.
• Intolerance to venipuncture
• Institutionalized volunteers.

• Age: 18 to 55 years old, both inclusive.
• Gender: Male and/or non-pregnant, non-lactating female.
• Female of child-bearing potential had a negative serum beta human chorionic gonadotropin (β HCG) pregnancy test performed within 28 days prior to first dosing day. They used an acceptable form of contraception. For female of child-bearing potential, acceptable forms of contraception included the following:
• Non hormonal intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or ii. Barrier methods containing or used in conjunction with a spermicidal agent, or iii. Surgical sterilization or iv. Practicing sexual abstinence throughout the course of the study.
• Female was not considered of child-bearing potential if one of the following was reported and documented on the medical history:
• Postmenopausal with spontaneous amenorrhea for at least one year, or ii. Spontaneous amenorrhea for more than 6 months and less than one year with Serum Follicular Stimulating Hormone (FSH) level > 40 mIU/mL, or iii. Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or iv. Total hysterectomy and an absence of bleeding for at least 3 months.
• BMI: 18.5 to 30.0 kg/m2, both inclusive; BMI value was rounded off to one significant digit after decimal point (e.g. 30.04 rounds down to 30.0, while 18.45 rounds up to 18.5).
• Volunteers had a body weight of more than 60 kg
• Non-smokers and non-tobacco users (i.e. had no past history of smoking and tobacco consuming for at least one year prior to study).
• Able to communicate effectively with study personnel.
• Willing to provide written informed consent to participate in the study.
• All volunteers were judged by the principal or sub-investigator or physician as normal and healthy during a pre-study safety assessment performed within 28 days of the first dose of study medication which will include:
  • A physical examination (clinical examination) with no clinically significant finding.