NCT06689436 - Pivotal BE Study of TAH3311 ODF vs ELIQUIS® Tablet Under Fasted Condition in Healthy Volunteers | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

November 16, 2024

Primary Completion Date

January 15, 2025

Study Completion Date

April 1, 2025

Conditions

Random AllocationIntermittent FastingEnteral Feeding

Interventions

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

Trial Locations (1)

89121

Novum Pharmaceutical Research Services, USA, Las Vegas

All Listed Sponsors

lead

TAHO Pharmaceuticals Ltd.

INDUSTRY