Study Comparing Esomeprazole and Acetylsalicylic Acid (ASA) Combined Together as One Capsule Versus These Medications Taken Separately

A Phase I, Open-Label, Randomized, Single-Centre, 3-Way Crossover Bioequivalence Study Comparing a Fixed Dose Combination Capsule of Esomeprazole 40 mg and Acetylsalicylic Acid 325 mg With Free Combinations of Esomeprazole Capsule 40 mg and Acetylsalicylic Acid Tablet 325 mg and Esomeprazole Tablet

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00998075

Enrollment

138

Registered

2009-10-20

Start date

2009-09-30

Completion date

2009-12-31

Last updated

2010-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peptic Ulcer Disease

Keywords

Bioequivalence, ASA, Esomeprazole, peptic ulcer disease, primary cardiovascular protection, healthy volunteers

Brief summary

The purpose of this study is to investigate whether treatment with a combination capsule of Esomeprazole 40 mg and Aspirin (ASA) 325 mg is bioequivalent (i.e.has the same effect within the body) as these medications taken separately. Two different forms of esomeprazole (tablets and capsules) will be investigated.

Interventions

DRUGEsomeprazole/ASA Fixed Combination

Capsule, oral, single dose

DRUGEsomeprazole - Nexium

Clinical Trial Capsule or MUPS Tablet, oral, single dose

DRUGASA

Tablet, oral, single dose

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

* Non-smoking male or female within the age range of 20 to 50 years * Body Mass Index (BMI = weight/height2) greater than or equal to 18.5 kg/m2 and less than or equal to 29.9 kg/m2

Exclusion criteria

* Documented upper gastrointestinal surgery * Use of any proton pump inhibitors or any bismuth preparations (e.g. Pepto-Bismol®) within 14 days preceding the screening visit

Design outcomes

Primary

Measure	Time frame
Plasma concentration-time curve from time 0 to the last quantifiable concentration for esomeprazole administered as fixed dose combination (FDC) to esomeprazole administered as free combinations	PK samples to be taken for bioanalysis over a 24-hour period following dosing on Day 1 of Period I and Day 1 of Period II and III.

Secondary

Measure	Time frame
Pharmacokinetics (PK): Total area under the plasma concentration-time curve (AUC0-inf), AUC0-t, Cmax, time to Cmax (Tmax), and half-life (t½) of esomeprazole	PK samples to be taken for bioanalysis over a 24-hour period following dosing for each treatment arm

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026