Early phase 1Completed
Comparative Bioavailability Study of TAH3311 5 mg Oral Dissolving Film vs ELIQUIS® 5 mg Tablet in Healthy Volunteers
A Phase I, Randomized, Single-Dose, Open-Label, Four-Way Crossover Study to Evaluate the Comparative Bioavailability of Apixaban for TAH3311 Oral Dissolving Film Versus ELIQUIS® Oral Tablet in Healthy Male and Female Subjects
- Sponsor
- TAHO Pharmaceuticals Ltd. (Industry)
- Enrolment
- 12 enrolled
- Conditions
- Healthy Volunteers; Fasting; Fed
- Interventions
- Apixaban 5 mg Oral Dissolving Film (TAH3311) and Tablet (Eliquis®)
- Ages
- adults, older adults
- Registry
- NCT05995119
Full record on ClinicalTrials.gov
From the registry
The goal of this clinical trial is to evaluate the pharmacokinetic profiles and bioequivalence, and to determine the safety and tolerability of the TAH3311 Oral Dissolving Film (ODF) 5mg compared with ELIQUIS® (Apixaban) 5mg Oral Tablet, after single dose under fasted and fed conditions in healthy volunteers.
Primary outcomes
- Plasma Concentration (Cmax) of Apixaban under fasted condition
- Area under the plasma concentration curve from time zero to last sampling time (AUC0-t) of Apixaban under fasted condition
- Area under the plasma concentration curve from time zero to infinity (AUC0-∞) of Apixaban under fasted condition
History
Last registry update
Registered
Study completion
Primary completion
Started