Pharmacokinetic Study Comparing Aspirin and Aspirin Granules

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01072604
First received: February 19, 2010
Last updated: April 18, 2014
Last verified: April 2014
  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


Condition Intervention Phase
Pharmacokinetics
Drug: Acetylsalicylic acid (Aspirin, BAY1019036)
Drug: Acetylsalicylic acid (Aspirin, BAYE4465)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Crossover Pharmacokinetic Trial of New Formula Aspirin Versus Aspirin Tablets and Aspirin Dry Granules in Healthy Adult Subjects

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess safety and tolerability of the new aspirin formula [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
  • To assess additional pharmacokinetic parameters [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: July 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Acetylsalicylic acid (Aspirin, BAY1019036)
One oral dose of new formula Aspirin Prototype 1 under fasting conditions
Experimental: Arm 2 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
Active Comparator: Arm 4 Drug: Acetylsalicylic acid (Aspirin, BAYE4465)
One oral dose of Aspirin Dry Granules under fasting conditions

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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), 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01072604

Locations
United States, New Jersey
Hackensack, New Jersey, United States, 07601
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01072604     History of Changes
Other Study ID Numbers: 14558
Study First Received: February 19, 2010
Last Updated: April 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Bayer:
Aspirin
Acetylsalicylic Acid

Additional relevant MeSH terms:
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 30, 2014