NCT05995119

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: TAHO Pharmaceuticals Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

For Treatment T1, the test product was administered orally at 30 minutes after the start of a standardized high-fat, high-calorie breakfast that was preceded by an overnight fast of at least 10 hours. For Treatment T2, the test product was administered orally following an overnight fast of at least 10 hours. The test treatment (1 × TAH3311 (apixaban) oral dissolving film 5 mg) was placed on the top of the tongue. Subjects were asked to close their mouth naturally and not to swallow for at least 60 seconds or until they felt that the film had fully dissolved. They were asked to indicate this to the dosing staff by raising their hand, who then verified. If any film remained in the mouth, after the subject raised his/her hand, the subject was reminded to not swallow and requested to close their mouth and allow the film to continue to dissolve and the study staff monitored the subject's mouth every 1 minute until such time that the film had fully dissolved. The time taken from dosing until the film had completely dissolved was documented. Dosing time was considered the time when the film was placed on the subject's tongue. No water was administered with the Test Treatments (T1 and T2). Reference Treatments (R1 \& R2): For Treatment R1, the reference product was administered orally at 30 minutes after the start of a standardized high-fat, high-calorie breakfast that was preceded by an overnight fast of at least 10 hours. For Treatment R2, the reference product was administered orally following an overnight fast of at least 10 hours. Each dose was administered with 240 mL of room temperature water. Subjects were instructed to swallow the tablet whole without chewing or biting. Any subject, who bit or chewed the tablet, was dropped from the study. Immediately after dosing a mouth check was performed to ensure that the tablet was swallowed whole without chewing or biting.

Conditions

• Healthy Volunteers
• Fasting
• Fed

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-12-05
• Primary completion: 2022-12-28
• Completion: 2023-01-13
• First posted: 2023-08-16
• Last updated: 2023-08-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study