Study Completed

Pharmacokinetics

Bayer Identifier:

14558

ClinicalTrials.gov Identifier:

NCT01072604

EudraCT Number:

Not Available

EU CT Number:

Not Available

Pharmacokinetic study comparing Aspirin and Aspirin granules

Trial purpose

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

Key Participants Requirements

Sex

Both

Age

18 - 55 Years

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)

Trial summary

Enrollment Goal

Trial Dates

July 2009 - August 2009

Phase

Phase 1

Could I Receive a placebo

Products

Bayer Advanced Aspirin (Acetylsalicylic acid, BAY1019036)

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Completed	Frontage Laboratories, LLC	Hackensack, 07601, United States

Primary Outcome

Bioequivalence of new formula aspirin relative to the established commercial aspirin plain tablet and aspirin dry granules when taken orally by healthy adult subjects
Time Frame:
24 hours
Safety Issue:
no

Secondary Outcome

To assess safety and tolerability of the new aspirin formula
Time Frame:
24 hours
Safety Issue:
yes
To assess additional pharmacokinetic parameters
Time Frame:
24 hours
Safety Issue:
no

Trial design

An Open Label Crossover Pharmacokinetic Trial of New Formula Aspirin versus Aspirin Tablets and Aspirin Dry Granules in Healthy Adult Subjects

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

Randomized

Blinding

Open Label

Assignment

Crossover Assignment

Trial Arms

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.