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Food Interaction Study To Assess the Effect of Food on the Pharmacokinetics of Esomeprazole 20 mg/Acetylsalicylic Acid 81 mg

NCT ID: NCT01163630

Last Updated: 2010-12-07

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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2010-09-30

Brief Summary

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The purpose of the study is to investigate the effects of food, in comparison to fasting conditions, on the extent and rate of absorption of acetylsalicylic acid (ASA) and esomeprazole.

Detailed Description

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Conditions

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Effect of Food Pharmacokinetics

Keywords

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open label, randomized single-center 2-way crossover food interaction study

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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1

esomeprazole 20mg/ASA 81 mg FDC after a 10-hour fast

Group Type EXPERIMENTAL

esomeprazole/ASA Fixed Dose Combination (FDC)

Intervention Type DRUG

esomeprazole 20 mg/ASA 81 mg oral capsule

2

esomeprazole 20mg/ASA 81 mg FDC 30 minutes after start of a high-fat, high-calorie breakfast

Group Type EXPERIMENTAL

esomeprazole/ASA Fixed Dose Combination (FDC)

Intervention Type DRUG

esomeprazole 20 mg/ASA 81 mg oral capsule

Interventions

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esomeprazole/ASA Fixed Dose Combination (FDC)

esomeprazole 20 mg/ASA 81 mg oral capsule

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy adults who provide informed consent prior to any study-related procedures. Females must be of non-child bearing potential.
* Weight of 50-95kg, inclusive, and a BMI between 19-30 kg/m2, inclusive.
* No clinically significant abnormal findings as judged by the Investigator on enrollment physical exam.

Exclusion Criteria

* Recent history of any clinically significant illness as judged by the Investigator within two weeks prior to enrolling in the study
* History of heart, kidney, liver. or gastrointestinal disease considered to be significant as judged by the Investigator
* Moderate to heavy smoking or other nicotine use (greater than 10 cigarettes per day or corresponding amount of nicotine)
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca

Principal Investigators

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Kelli Craven, MD

Role: PRINCIPAL_INVESTIGATOR

Quintiles, Inc.

Ken Price

Role: STUDY_DIRECTOR

AstraZeneca

Mirjana Kujacic

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Oveland Park, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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D961FC00009

Identifier Type: -

Identifier Source: org_study_id