A Bioequivalence Study to Compare the Pharmacokinetics of Two Betrixaban Formulations

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2015-11-30

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.

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Detailed Description

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Serial blood samples will be obtained for PK evaluation.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Tablet

80mg immediate release tablet

Group Type EXPERIMENTAL

Betrixaban

Intervention Type DRUG

Capsule

80mg immediate release capsule

Group Type EXPERIMENTAL

Betrixaban

Intervention Type DRUG

Interventions

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Betrixaban

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes