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Pivotal BE Study of TAH3311 ODF vs ELIQUIS® Tablet Under Fasted Condition in Healthy Volunteers

NCT06689436 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-04-11

No results posted yet for this study

Summary

This single-dose, open-label, randomized, four-way crossover study evaluates the pharmacokinetics, safety, and tolerability of TAH3311 5 mg in healthy volunteers under fasted and fed conditions.

Conditions

  • Random Allocation
  • Intermittent Fasting
  • Enteral 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

Sponsors & Collaborators

  • TAHO Pharmaceuticals Ltd.

    lead INDUSTRY

Principal Investigators

  • Tiffany A Bradley, MD · Novum Pharmaceutical Research Services

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-16
Primary Completion
2025-01-15
Completion
2025-04-01
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 NCT06689436 on ClinicalTrials.gov