NCT06689436

Pivotal BE Study of TAH3311 ODF vs ELIQUIS® Tablet Under Fasted Condition in Healthy Volunteers

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: TAHO Pharmaceuticals Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Random Allocation
• Intermittent Fasting
• Enteral Feeding

Interventions

Type	Name	Description
DRUG	5 mg Apixaban Oral Dissolving Film (fasting)	Single dose of 5 mg Apixaban Oral Dissolving Film will be administered orally after at least 10 hours overnight fast
DRUG	5 mg Apixaban Oral Dissolving Film (fed)	Single dose of 5 mg Apixaban Oral Dissolving Film will be administered orally at 30 minutes after the start of a standardized high-fat, high-calorie breakfast that is preceded by at least 10 hours overnight fast
DRUG	5 mg Apixaban Oral Tablet (US RS/RLD)	Single dose of 5 mg Apixaban Oral Tablet (US RS/RLD) will be administered orally after at least 10 hours overnight fast
DRUG	5 mg Apixaban Oral Tablet (EU product)	Single dose of 5 mg Apixaban Oral Tablet (EU product) will be administered orally after at least 10 hours overnight fast

Timeline

• Start date: 2024-11-16
• Primary completion: 2025-01-15
• Completion: 2025-04-01
• First posted: 2024-11-14
• Last updated: 2025-04-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study