DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Pharmacokinetic Study Comparing Aspirin and Effervescent Aspirin

Information source: Bayer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pharmacokinetics

Intervention: Acetylsalicylic Acid (Aspirin BAY1019036) (Drug); Alka Seltzer Extra Strength (Drug); Aspirin Migraine (Drug); Aspirin Aspro (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

Summary

To determine the bioequivalence of new formula of aspirin relative to the established commercial effervescent aspirin when taken orally by healthy adult subjects

Clinical Details

Official title: An Open Label 4-Way Crossover Pharmacokinetic Trial of New Formula Aspirin Versus Effervescent Aspirin in Healthy Adult Subjects

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Bioavailability of new formulation aspirin versus marketed effervescent tablets (500mg aspirin)

Secondary outcome: Adverse event collection

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

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), Nonsteroidal Antiinflammatory Drugs

(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 (Over the

counter (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)

Locations and Contacts

Hackensack, New Jersey 07601, United States
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.

Starting date: February 2010
Last updated: June 25, 2014

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017