Pharmacokinetic Study Comparing Aspirin and Aspirin Granules

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2009-08-31

Brief Summary

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

To determine the bioequivalence of new formula of aspirin relative to the established commercial aspirin plain tablet and aspirin dry granules when taken orally by healthy adult subjects

Related Clinical Trials

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

To Evaluate the Bioavailability of a Single Oral Dose of the Acetylsalicylic Acid Containing Dry Powder 500 mg in Comparison to the Bioavailability of a Single Oral Dose of Aspirin Tablets and Aspirin Effervescent Tablets in Healthy Adults.

NCT02394093

Pharmacology, Clinical

COMPLETED PHASE1

Bioequivalence of Single Dose Fast Release Aspirin (1000 mg) Tablet Versus Single Dose of Two 500 mg Fast Release Aspirin Tablets

NCT03056703

Pain

COMPLETED PHASE1

A Study to Learn if There is a Difference in the Blood Levels of Acetylsalicylic Acid When Taken as Different Chewable Tablets on an Empty Stomach by Healthy Participants

NCT06655194

Bioequivalence Healthy Volunteers Platelet Aggregation Inhibition

COMPLETED PHASE1

Pharmacokinetic and Pharmacodynamic Assessment of a Novel, Pharmaceutical Lipid-Aspirin Complex

NCT04008979

Bioequivalence

COMPLETED PHASE1

Randomized, Crossover Bioequivalence Study of PL-ASA Versus Immediate Release Aspirin in Healthy Volunteers.

NCT05055752

Bioequivalence

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.

Pharmacokinetics

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

Arm 1

Group Type EXPERIMENTAL

Acetylsalicylic acid (Aspirin, BAY1019036)

Intervention Type DRUG

One oral dose of new formula Aspirin Prototype 1 under fasting conditions

Arm 2

Group Type EXPERIMENTAL

Acetylsalicylic acid (Aspirin, BAY1019036)

Intervention Type DRUG

One oral dose of new formula Aspirin Prototype 2 under fasting conditions

Arm 3

Group Type ACTIVE_COMPARATOR

Acetylsalicylic acid (Aspirin, BAYE4465)

Intervention Type DRUG

One oral dose of Aspirin Plain Tablet under fasting conditions

Arm 4

Group Type ACTIVE_COMPARATOR

Acetylsalicylic acid (Aspirin, BAYE4465)

Intervention Type DRUG

One oral dose of Aspirin Dry Granules under fasting conditions

Interventions

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

Acetylsalicylic acid (Aspirin, BAY1019036)

One oral dose of new formula Aspirin Prototype 1 under fasting conditions

Intervention Type DRUG

Acetylsalicylic acid (Aspirin, BAY1019036)

One oral dose of new formula Aspirin Prototype 2 under fasting conditions

Intervention Type DRUG

Acetylsalicylic acid (Aspirin, BAYE4465)

One oral dose of Aspirin Plain Tablet under fasting conditions

Intervention Type DRUG

Acetylsalicylic acid (Aspirin, BAYE4465)

One oral dose of Aspirin Dry Granules under fasting conditions

Intervention Type DRUG

Eligibility Criteria

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

Inclusion Criteria

* Healthy male and female subjects between 18 to 55 years of age inclusive with a Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight \>50 kg (110 lbs)
* Results of screening and clinical laboratory tests are within normal range or considered not clinically significant by the Principal Investigator or Sponsor
* Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, Depo-Provera, or a double barrier and have a negative pregnancy test at Screening and Day 0 for each Dosing Period. Female subjects of non-childbearing potential must be amenorrheic for at least 2 years or had a hysterectomy and/or bilateral oophorectomy
* Be willing to participate in all scheduled visits, treatment plan, laboratory tests and other trial procedures according to the clinical protocol

Exclusion Criteria

* History of hypersensitivity to aspirin (ASA), NSAIDs, acetaminophen and similar pharmacological agents or components of the products
* Eighteen to twenty year olds with a viral infection, with or without fever, at the time of dosing
* Syndromes of asthma, rhinitis or nasal polyps
* Females who are pregnant or lactating
* Have taken ASA, ASA-containing products, acetaminophen or any other NSAID (OTC or prescription) 7 days prior to dosing or during the treatment period, other than trial treatment
* Smokers or currently consuming any type of tobacco product(s) including any smoking cessation nicotine-containing product (e.g., nicotine patch, nicotine gum)

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes