Comparative Bioavailability Study of TAH3311 5 mg Oral Dissolving Film vs ELIQUIS® 5 mg Tablet in Healthy Volunteers

Inclusion criteria

• ✓. Males and non-pregnant, non-lactating females, 18-80 years of age, inclusive.
• ✓. A minimum body weight of 60 kg and a Body Mass Index (BMI) of 18.5-29.9 kg/m², inclusive. BMI will be calculated using Novum Pharmaceutical Research Services Standard Operating Procedures.
• ✓. Female subjects must meet at least one of the following requirements:
• ✓. Male subjects who are not surgically sterile must agree to abstain from sexual intercourse (complete abstinence) or use appropriate contraceptive measures and agree to not impregnate a female partner(s) and not to donate sperm throughout the entire study, including the washout periods, and for 30 days after the last study drug administration. Examples of acceptable methods of contraception include a double-barrier method of contraception (e.g., condom with spermicide). Other forms of contraception may be acceptable, at the discretion of the Investigator.
• ✓. Subject is judged by an Investigator to be in good health as determined by lack of clinically significant abnormalities in health assessments performed at screening. Any abnormalities or deviations outside the normal ranges for any clinical testing (e.g., laboratory tests, ECG, vital signs) may be repeated, at the discretion of the Investigator(s), and judged by an Investigator to be not clinically significant for study participation.
• ✓. Subject doesn't have any relevant dietary restrictions, as determined by the Investigator, and is willing to consume a high-fat, high-calorie breakfast and other standard meals provided during the treatment periods of the study, and to comply with the fasting conditions required by the study design.
• ✓. Subject is able to read and speak English fluently. Subjects will be required to read, understand, sign and date the informed consent form, which meets all criteria of current FDA regulations, and must be able to understand the information and instruction given to them during the study.

Exclusion criteria