Pivotal BE Study of TAH3311 ODF vs ELIQUIS® Tablet Under Fasted Condition in Healthy Volunteers
brief summary
This single-dose, open-label, randomized, four-way crossover study evaluates the pharmacokinetics, safety, and tolerability of TAH3311 5 mg in healthy volunteers under fasted and fed conditions.
detailed description
Eligible subjects will be enrolled in the study across four sequences (anticipate 15 subjects per sequence). This study will have three phases: Screening Phase, Treatment Phase, and Follow-Up Phase. Subjects will be randomized 1:1:1:1 to receive TAH3311 ODF 5 mg under fasted (T1) and fed conditions (T2) and ELIQUIS® 5 mg (US RS/RLD \[R1\] and EU product \[R2\]) under fasted condition via one of the four sequences with serial PK sampling from 90 minutes pre-dose to 48 hours post-dose. The duration of each treatment period is 4 days, with a 7±2 days washout in between of the treatment administration. The follow-up period will be 7±3 days after the last treatment dosing.
official title
A Pivotal, Randomized, Single-dose, Open-label, Four-Way Crossover, BE Study of TAH3311 (Apixaban ODF) Under Fasted and Fed Conditions vs. ELIQUIS® Oral Tablet Under Fasted Condition in Healthy Volunteers