MedDataX Logo

Evaluate Relative Bioavailability of PA32540 (Asa/Omeprazole), Its Aspirin Component, and Ecotrin® in Healthy Volunteers

NCT ID: NCT00632086

Last Updated: 2008-03-10

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

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2008-02-29

Brief Summary

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

Study to determine a single dose bioavailablity of PA32540 is similar to EC aspirin 325 mg with respect to salicylic acid.

Related Clinical Trials

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

Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PA32540 or Enteric Coated Aspirin 325 mg in Subjects Who Are at Risk for Developing Aspirin-Associated Ulcers

NCT00960869

Gastric Ulcer
COMPLETED PHASE3

To Compare the Gastroprotective Effects and Pharmacokinetic Profile of PA Versus Enteric-Coated Aspirin

NCT00442052

Healthy
COMPLETED PHASE1

Study Evaluating the Effect on Gastroduodenal Mucosa of PA32540, PA32540 and Celecoxib, and Aspirin With Celecoxib

NCT00700687

Healthy
COMPLETED PHASE1

A Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PA32540 or Enteric Coated Aspirin 325 mg in Subjects Who Are at Risk for Developing Aspirin-Associated Ulcers

NCT00961350

Gastric Ulcer
COMPLETED PHASE3

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

NCT00998075

Peptic Ulcer Disease
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.

Healthy

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

Single oral dose of 325 mg aspirin administered as PA32540

Group Type EXPERIMENTAL

PA32540

Intervention Type DRUG

2

aspirin core

Group Type EXPERIMENTAL

aspirin component of PA32540

Intervention Type DRUG

The 325 mg aspirin component of PA32540

3

active

Group Type ACTIVE_COMPARATOR

Ecotrin

Intervention Type DRUG

325 mg Ecotrin

Interventions

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

PA32540

Intervention Type DRUG

aspirin component of PA32540

The 325 mg aspirin component of PA32540

Intervention Type DRUG

Ecotrin

325 mg Ecotrin

Intervention Type DRUG

Eligibility Criteria

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

Inclusion Criteria

* Standard for PK
* Ages 18-55 years old
* Males and females

Exclusion Criteria

* Standard for PK
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

POZEN

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Pozen

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PA32540-104

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Phase III, Randomized, Study of Aspirin and Esomeprazole Chemoprevention in Barrett's Metaplasia
NCT00357682 COMPLETED PHASE3
Pharmacological Study That Measures Omeprazole Effect on Aspirins Absorption in Healthy Volunteers
NCT01061034 COMPLETED NA
Study to Evaluate the Interaction Between Aspirin and Nexium
NCT01199328 COMPLETED PHASE1
Study Comparing Esomeprazole and ASA Combined Together as One Capsule Versus These Medications Taken Separately
NCT01015729 TERMINATED PHASE1
Study Comparing a Fixed-Dose Capsule of Esomeprazole 40mg and LDA 325mg With Free Combination
NCT00688428 COMPLETED PHASE1
A Parallel Group Study to Compare the Gastroprotective Effects of PA 325 Versus 81 mg Enteric Coated Aspirin
NCT00441519 COMPLETED PHASE1
Efficacy of Esomeprazole in Patients With Frequent Heartburn
NCT01370525 COMPLETED PHASE3
Esomeprazole Magnesium With or Without Aspirin in Preventing Esophageal Cancer in Patients With Barrett Esophagus
NCT00474903 COMPLETED PHASE2
ASTERIX: Low Dose ASA and Nexium
NCT00251966 COMPLETED PHASE3
Study to Assess the Bioequivalence Between D961S and Esomeprazole/Buffered Acetylsalicylic Acid (ASA) in Japanese Healthy Male Subjects
NCT01494402 COMPLETED PHASE1
Food Interaction Study To Assess the Effect of Food on the Pharmacokinetics of Esomeprazole 20 mg/Acetylsalicylic Acid 81 mg
NCT01163630 COMPLETED PHASE1
Efficacy of Esomeprazole in Patients With Frequent Heartburn
NCT01370538 COMPLETED PHASE3
Comparative Efficacy & Safety Study of D961H Versus Placebo for the Prevention of Gastric and Duodenal Ulcers With Low-dose Aspirin
NCT01069939 COMPLETED PHASE3
Study to Evaluate the Long-Term Safety of PA32540 in Subjects Who Are at Risk for Developing Aspirin-Associated Gastric Ulcers
NCT00995410 COMPLETED PHASE3
A Dose-finding Phase IIb Study With AZD0865 and Esomeprazole in GERD Patients Without Erosive Esophagitis.
NCT00206284 COMPLETED PHASE2
Esomeprazole And Symptomatic Response In Patients With Or Without An Elevated Risk For Non-Steroidal Anti-Inflammatory Drug (NSAID)-Associated GI Damage
NCT00524329 COMPLETED
A Study to Examine the Effect of Omeprazole, Famotidine, and an Acidic Beverage on the Pharmacokinetics of Entinostat in Healthy Adult Subjects
NCT02922933 COMPLETED PHASE1
A Multicenter, Randomized, Double-Blind Parallel-Group, Placebo-Controlled Efficacy Study Comparing 4 Weeks of Treatment With Esomeprazole 20 mg Once Daily to Placebo qd for the Resolution of Upper Abdominal Pain in Patients With Symptomatic Gastroesophageal Reflux Disease (sGERD)
NCT00626535 COMPLETED PHASE3
A Study to Evaluate the Effect of Multiple Doses of Esomeprazole on the Pharmacokinetics of Isavuconazole
NCT02128893 COMPLETED PHASE1
A Study in Healthy Men to Test Whether Esomeprazole Influences the Amount of BI 3000202 in the Blood
NCT06419660 COMPLETED PHASE1
A Comparison of Two Therapeutic Strategies for the Treatment of Aspirin-associated Peptic Ulcers
NCT01353144 COMPLETED PHASE4
A Study to Investigate the Relative Bioavailability of 2 Different Formulations of AZD4144, the Effect of Food and Omeprazole on the Pharmacokinetics of AZD4144 in Healthy Participants
NCT06948006 COMPLETED PHASE1
A Study to Compare Bioavailability of AZD5055 Film-coated Tablet With AZD5055 Oral Suspension and to Assess the Effect of Food and an Acid Reducing Agent on Pharmacokinetics (PK) of AZD5055 in Healthy Subjects.
NCT05630677 COMPLETED PHASE1
Esomeprazole in Treatment of Early Onset Preeclampsia (ESOPE Trial)
NCT03213639 COMPLETED PHASE2/PHASE3
Study of Esomeprazole 20 mg or 40 mg vs Placebo Effectiveness on the Occurrence of Peptic Ulcers in Subjects on Low Dose Acetylsalicylic Acid (LDA)
NCT00441727 COMPLETED PHASE3