Phase 1 Drug Interaction Study of Apixaban and Atenolol in Healthy Subjects

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

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2007-06-30

Brief Summary

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The purpose of this study is to assess the effect of Atenolol 100 mg on the Pharmacokinetics (PK) of Apixaban and the effect of Apixaban 10 mg on the PK of Atenolol in Healthy subjects.

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Detailed Description

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Conditions

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N/A - Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Treatment A: Apixaban

Apixaban tablet by mouth on specified day

Group Type EXPERIMENTAL

Apixaban

Intervention Type DRUG

Treatment B: Atenolol

Atenolol tablet by mouth on specified day

Group Type EXPERIMENTAL

Atenolol

Intervention Type DRUG

Treatment C: Apixaban and Atenolol

Apixaban and Atenolol tablets by mouth on specified day

Group Type EXPERIMENTAL

Apixaban

Intervention Type DRUG

Atenolol

Intervention Type DRUG

Interventions

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Apixaban

Intervention Type DRUG

Atenolol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiogram (ECGs), and clinical laboratory determinations

Exclusion Criteria

* Any significant acute or chronic medical illness, history of hypotension, history or evidence of abnormal bleeding or coagulation disorders, significant head injury within the last 2 years

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes