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CompletedNCT00688428Updated Mar 12, 2009

Study Comparing a Fixed-Dose Capsule of Esomeprazole 40mg and LDA 325mg With Free Combination

A Phase 1 interventional study of Esomeprazole 40mg/ASA 325mg and Esomeprazole in Ulcers and Upper GI Symptoms, sponsored by AstraZeneca. Completed. Open to participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-03-12.

Sponsored by AstraZeneca · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
84
Allocation
Randomized
Ages
20 Years to 50 Years
Sex
All
01

Study summary

The purpose of this study is to test if fixed dose esomeprazole and ASA capsule is pharmaceutically equal to a free combination of esomeprazole capsule and ASA tablet

02

Conditions studied

  • Ulcers
  • Upper GI Symptoms

Keywords

  • esomeprazole
  • upper gi symptoms
  • low dose Aspirin treatment
03

In context

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Body mass index of 19-29kg/m2, inclusive
  • Weight of 50-95kg, inclusive
  • Clinically normal physical findings and laboratory values including hepatitis B, hepatitis C, and HIV, as judged by the Investigator

Exclusion criteria

Exclusion Criteria:

  • Significant clinical illness within the 2 weeks preceding the first dose of investigational products, as judged by the Investigator
  • History of mental, cardiac, renal, hepatitis, neurological, or significant gastrointestinal disease, as judged by the Investigator
  • Condition which could modify the absorption of the investigational products, as judged by the Investigator
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
84 participants (estimated)

Study arms

  • Experimental
    1

    combination capsule of Esomeprazole 40mg + ASA 325mg

    Drug: Esomeprazole 40mg/ASA 325mg

  • Experimental
    2

    Esomeprazole 40 mg capsule and ASA 325 mg tablet

    Drug: Esomeprazole · Drug: ASA

Interventions

  • DrugEsomeprazole 40mg/ASA 325mg

    combination capsule, administered as a single oral dose

    Also known as: Nexium/Bayer Aspirin

  • DrugEsomeprazole

    40mg capsule, administered as a single dose

    Also known as: Nexium

  • DrugASA

    325mg tablet, administered as a single oral dose

    Also known as: Bayer aspirin

06

What researchers measure

Primary outcomes

  1. Samples for measurement of esomeprazole, ASA, and SA concentrations

    Time frame: Day 1 of each period

Secondary outcomes

  1. Fasting blood samples for determination of clinical chemistry and hematology parameters

    Time frame: screening and follow up visit

  2. urine samples for urinalysis parameters

    Time frame: screening, Period 1, and follow-up visit

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00688428
Lead sponsor
AstraZeneca
First posted
Jun 3, 2008
Start date
Apr 2008
Primary completion
Apr 2008
Completion
Apr 2008
Last update
Mar 12, 2009

Study contacts

Jörgen Naesdal, M.D.
study director · AstraZeneca
Christopher Billings ., D.O
principal investigator · Biokinetics Clinical Applications

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2009. You cannot join it, but the record below documents what was studied.

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