A Bioequivalence Study to Compare the Pharmacokinetics of Two Betrixaban Formulations

Study Overview
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Brief Summary
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This is a single center open label randomized 4-period 2-sequence replicated crossover design study. A total of 52 healthy subjects will be randomized.

Detailed Description
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Serial blood samples will be obtained for PK evaluation.

Official Title
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A Bioequivalence Study to Compare the Pharmacokinetics of Two Betrixaban Formulations

Conditions
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Healthy

Intervention / Treatment
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* Drug: Betrixaban


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All inclusion criteria must be satisfied within 30 days of enrollment and must be documented in the source documents. A healthy man or woman between the ages of 18 and 60 Has no clinically significant findings in medical history, physical examination, EKG and vital signs Weighs > 45 kg (99 lbs.) and has body mass index (BMI) < 30 kg/m2 Agrees to abstain from alcohol consumption for 48 hrs prior to dosing and for the duration of each of the study in-house periods Is a non-smoker or light smoker (no more than the equivalent of five cigarettes per day) and agrees to abstain from smoking for the duration of each of the study in-house periods Exclusion Criteria: None of the exclusion criteria may be present for enrollment Known history (including family history) or symptoms of any clinically significant bleeding (i.e. a bleeding that required medical attention) or a vascular malformation Major surgery, severe trauma or bone fracture within 3 months of the first dose of the study drug or a planned surgery within 1 month after the last dose of the study drug History of blood donation of more than 500 mL within 3 months prior to the first dose of the study drug History of alcohol abuse (greater than 3 alcoholic beverages per day) Positive screen for drugs of abuse Positive serology test for HIV, Hepatitis B or C Has any allergy or sensitivity to fXa inhibitors

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tablet<br>80mg immediate release tablet | Drug: Betrixaban<br> <br> |
| Experimental: Capsule<br>80mg immediate release capsule | Drug: Betrixaban<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence analysis using total area under the curve (Total AUC) after a single dose of Betrixaban in healthy subjects |  | 120 hours | 
| Bioequivalance analysis using peak concentration in plasma (Cmax) after a single dose of Betrixaban in healthy volunteers |  | 120 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioequivalence