Pharmacokinetic Study Comparing Aspirin and Effervescent Aspirin

Pharmacokinetics Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01081353
• Other study ID #: 14961
• Status: Completed
• Phase: Phase 1
• First received: March 4, 2010
• Last updated: June 25, 2014
• Start date: February 2010
• Est. completion date: March 2010

Study information

• Verified date: June 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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)

Study Design

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

Related Conditions & MeSH terms

• Pharmacokinetics

Intervention

Drug:
• Acetylsalicylic Acid (Aspirin BAY1019036)
One tablet of new formula Aspirin under fasting conditions
• Alka Seltzer Extra Strength
One effervescent tablet under fasting conditions
• Aspirin Migraine
One effervescent tablet under fasting conditions
• Aspirin Aspro
One effervescent tablet under fasting conditions

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioavailability of new formulation aspirin versus marketed effervescent tablets (500mg aspirin)		24 hours	No
Secondary	Adverse event collection		24 hours	Yes

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