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

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2008-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT00998075

Peptic Ulcer Disease

COMPLETED PHASE1

Study Comparing Esomeprazole and ASA Combined Together as One Capsule Versus These Medications Taken Separately

NCT01015729

Peptic Ulcer Disease

TERMINATED PHASE1

Bioequivalence Study of Torrent Pharmaceutical Ltd's Esomeprazole Magnesium Delayed Release Capsules

NCT02680132

Healthy

COMPLETED PHASE1

A Dose-finding Phase IIb Study With AZD0865 and Esomeprazole in GERD Patients Without Erosive Esophagitis.

NCT00206284

GERD Without Erosive Esophagitis

COMPLETED PHASE2

Study to Assess the Bioequivalence Between D961S and Esomeprazole/Buffered Acetylsalicylic Acid (ASA) in Japanese Healthy Male Subjects

NCT01494402

Bioequivalence Study

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ulcers Upper GI Symptoms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

combination capsule of Esomeprazole 40mg + ASA 325mg

Group Type EXPERIMENTAL

Esomeprazole 40mg/ASA 325mg

Intervention Type DRUG

combination capsule, administered as a single oral dose

2

Esomeprazole 40 mg capsule and ASA 325 mg tablet

Group Type EXPERIMENTAL

Esomeprazole

Intervention Type DRUG

40mg capsule, administered as a single dose

ASA

Intervention Type DRUG

325mg tablet, administered as a single oral dose

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Esomeprazole 40mg/ASA 325mg

combination capsule, administered as a single oral dose

Intervention Type DRUG

Esomeprazole

40mg capsule, administered as a single dose

Intervention Type DRUG

ASA

325mg tablet, administered as a single oral dose

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Nexium/Bayer Aspirin Nexium Bayer aspirin

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

* 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

Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes