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

NCT01163630 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2010-12-07

No results posted yet for this study

Summary

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.

Conditions

  • Effect of Food
  • Pharmacokinetics

Interventions

DRUG

esomeprazole/ASA Fixed Dose Combination (FDC)

esomeprazole 20 mg/ASA 81 mg oral capsule

Sponsors & Collaborators

Principal Investigators

  • Kelli Craven, MD · Quintiles, Inc.

  • Ken Price · AstraZeneca

  • Mirjana Kujacic · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • United States

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Entities

Companies

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 NCT01163630 on ClinicalTrials.gov