Pharmacokinetic Study Comparing Aspirin and Aspirin Granules

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

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

Study Overview

• Status: Completed
• Conditions: Pharmacokinetics
• Intervention / Treatment: Drug: Acetylsalicylic acid (Aspirin, BAY1019036); Drug: Acetylsalicylic acid (Aspirin, BAY1019036); Drug: Acetylsalicylic acid (Aspirin, BAYE4465); Drug: Acetylsalicylic acid (Aspirin, BAYE4465)

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Hackensack, New Jersey, United States, 07601

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1	Drug: Acetylsalicylic acid (Aspirin, BAY1019036); One oral dose of new formula Aspirin Prototype 1 under fasting conditions; Drug: Acetylsalicylic acid (Aspirin, BAY1019036); One oral dose of new formula Aspirin Prototype 2 under fasting conditions
Experimental: Arm 2	Drug: Acetylsalicylic acid (Aspirin, BAY1019036); One oral dose of new formula Aspirin Prototype 1 under fasting conditions; Drug: Acetylsalicylic acid (Aspirin, BAY1019036); One oral dose of new formula Aspirin Prototype 2 under fasting conditions
Active Comparator: Arm 3	Drug: Acetylsalicylic acid (Aspirin, BAYE4465); One oral dose of Aspirin Plain Tablet under fasting conditions; Drug: Acetylsalicylic acid (Aspirin, BAYE4465); One oral dose of Aspirin Dry Granules under fasting conditions
Active Comparator: Arm 4	Drug: Acetylsalicylic acid (Aspirin, BAYE4465); One oral dose of Aspirin Plain Tablet under fasting conditions; Drug: Acetylsalicylic acid (Aspirin, BAYE4465); One oral dose of Aspirin Dry Granules under fasting conditions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Bioequivalence of new formula aspirin relative to the established commercial aspirin plain tablet and aspirin dry granules when taken orally by healthy adult subjects	24 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
To assess safety and tolerability of the new aspirin formula	24 hours
To assess additional pharmacokinetic parameters	24 hours

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): August 1, 2009
• Study Completion (Actual): August 1, 2009

Study Registration Dates

• First Submitted: February 19, 2010
• First Submitted That Met QC Criteria: February 19, 2010
• First Posted (Estimate): February 22, 2010

Study Record Updates

• Last Update Posted (Estimate): April 21, 2014
• Last Update Submitted That Met QC Criteria: April 18, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Aspirin; Acetylsalicylic Acid
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin
• Other Study ID Numbers: 14558