Pharmacokinetic Study Comparing Aspirin and Effervescent Aspirin

NCT01081353 | Completed Phase 1 DMC

• 1 other identifier: 14961
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pharmacokinetics

Keywords

Aspirin; Acetylsalicylic Acid

Outcome Measures

Primary Outcomes (1)

• Bioavailability of new formulation aspirin versus marketed effervescent tablets (500mg aspirin)

  24 hours

Secondary Outcomes (1)

• Adverse event collection

  24 hours

Study Arms (4)

Arm 1

EXPERIMENTAL

Drug: Acetylsalicylic Acid (Aspirin BAY1019036)

Arm 2

ACTIVE COMPARATOR

Drug: Alka Seltzer Extra Strength

Arm 3

ACTIVE COMPARATOR

Drug: Aspirin Migraine

Arm 4

ACTIVE COMPARATOR

Drug: Aspirin Aspro

Interventions

Acetylsalicylic Acid (Aspirin BAY1019036) DRUG

One tablet of new formula Aspirin under fasting conditions

Arm 1

Alka Seltzer Extra Strength DRUG

One effervescent tablet under fasting conditions

Arm 2

Aspirin Migraine DRUG

One effervescent tablet under fasting conditions

Arm 3

Aspirin Aspro DRUG

One effervescent tablet under fasting conditions

Arm 4

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Hackensack, New Jersey, 07601, United States

Location

MeSH Terms

Interventions

Aspirin; Glutaredoxins

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Oxidoreductases Acting on Sulfur Group Donors; Oxidoreductases; Enzymes; Enzymes and Coenzymes

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2010
• First Posted: March 5, 2010
• Study Start: February 1, 2010
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: June 26, 2014

Record last verified: 2014-06

Locations

US (1)