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

NCT05995119 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-08-18

No results posted yet for this study

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.

Conditions

  • Healthy Volunteers
  • Fasting
  • Fed

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.

Sponsors & Collaborators

  • TAHO Pharmaceuticals Ltd.

    lead INDUSTRY

Principal Investigators

  • Philip Mathew, M.D. · Novum Pharmaceutical Research Services, USA

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-05
Primary Completion
2022-12-28
Completion
2023-01-13
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05995119 on ClinicalTrials.gov