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

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

December 5, 2022

Primary Completion Date

December 28, 2022

Study Completion Date

January 13, 2023

Conditions
Healthy VolunteersFastingFed
Interventions
DRUG

Apixaban 5 mg Oral Dissolving Film (TAH3311) and Tablet (Eliquis®)

The subjects were administered either the test (TAH3311 5 mg ODF as Treatment T1) or reference (ELIQUIS® 5 mg oral tablet as Treatment R1) product at 30 minutes following the start of a standardized high-fat, high-calorie breakfast that was preceded by an overnight fast of at least 10 hours. In the other two study periods, the subjects were administered either the test (Treatment T2) or reference (Treatment R2) product following an overnight fast of at least 10 hours. The subjects received the test and reference products in accordance with a four-sequence randomization schedule. There was a washout period of 5 days between the dosing days of any two consecutive periods.

Trial Locations (1)

89121

Novum Pharmaceutical Research Services, Las Vegas

All Listed Sponsors
lead

TAHO Pharmaceuticals Ltd.

INDUSTRY