check_circleStudy Completed

Pain

Bayer Identifier:

16645

ClinicalTrials.gov Identifier:

NCT03056703

EudraCT Number:

Not Available

EU CT Number:

Not Available
Bioequivalence of single dose fast release aspirin (1000 mg) tablet versus single dose of two 500 mg fast release aspirin tablets

Trial purpose

The primary objective of this study is to compare the bioavailability of a single dose of a new 1000 mg fast release ASA (acetylsalicylic acid) tablet with that of two tablets of a commercially available 500 mg fast release tablet and to test for bioequivalence of the new versus the commercial product in healthy adult subjects.

Key Participants Requirements

Sex

Both

Age

18 - 55 Years
  • - Healthy ambulatory male and female subjects 18 to 55 years of age, inclusive
    - Body Mass Index (BMI) of approximately 18.5 to 30.0 kg/m2, and a total body weight >50 kg (110 lbs)
    - Results of screening and clinical laboratory tests are within normal limits 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, intramuscular injection or double-barrier and have a negative pregnancy test at Screening and on Day 0 of each treatment period. Female subjects of nonchildbearing potential must be amenorrheic for at least 2 years or had a hysterectomy and/or bilateral oophorectomy.
    - Provide a personally signed and dated informed consent prior to inclusion in the trial indicating that the subject has been informed of all pertinent aspects of the trial.
  • - History of hypersensitivity to acetylsalicylic acid (ASA), naproxen sodium, acetaminophen, other non-steroidal anti-inflammatory drugs (NSAIDs), and similar pharmacological agents or components of the products
    - History of gastrointestinal bleeding or perforation, including bleeding related to previous NSAID therapy. Active, or history of recurrent peptic ulcer/hemorrhage (two or more distinct episodes of proven ulceration or bleeding).
    - Have taken ASA, ASA-containing products, acetaminophen or any other NSAID (OTC or prescription) seven days prior to dosing or during the Treatment Periods, other than study product
    - Loss of blood in excess of 500 mL within 56 days of the first dose of trial treatment (e.g., donation, plasmapheresis, or injury)
    - Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic disease, or malignancies
    - Positive alcohol or drug screen at Screening or on Day 0 of Treatment Periods 1 or 2
    - Females who are pregnant or lactating
    - Consumption of xanthine-containing food and beverages within 24 h before investigational medicinal product (IMP) administration during Treatment Periods 1 and 2; or not willing to abstain from any xanthine containing food and beverages during the study

Trial summary

Enrollment Goal
38
Trial Dates
February 2014 - March 2014
Phase
Phase 1
Could I Receive a placebo
No
Products
Bayer Advanced Aspirin (Acetylsalicylic acid, BAY1019036)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Hackensack, 07601, United States

Primary Outcome

  • AUC0-inf (area under plasma concentration versus time curve) for ASA (acetylsalicylic acid)
    date_rangeTime Frame:
    baseline (pre-dose) and 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 35, 40, 45, 50, 55 minutes and 1. 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose
    enhanced_encryption
    Safety Issue:
    No
  • AUC0-t for ASA
    date_rangeTime Frame:
    baseline (pre-dose) and 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 35, 40, 45, 50, 55 minutes and 1. 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Cmax (maximum plasma concentration) for ASA
    date_rangeTime Frame:
    baseline (pre-dose) and 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 35, 40, 45, 50, 55 minutes and 1. 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • AUC0-inf for SA (salicylic acid)
    date_rangeTime Frame:
    baseline (pre-dose) and 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 35, 40, 45, 50, 55 minutes and 1. 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose
    enhanced_encryption
    Safety Issue:
    No
  • AUC0-t for SA
    date_rangeTime Frame:
    baseline (pre-dose) and 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 35, 40, 45, 50, 55 minutes and 1. 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Cmax for SA
    date_rangeTime Frame:
    baseline (pre-dose) and 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 35, 40, 45, 50, 55 minutes and 1. 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose
    enhanced_encryption
    Safety Issue:
    No
  • t1/2 for ASA and SA
    date_rangeTime Frame:
    baseline (pre-dose) and 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 35, 40, 45, 50, 55 minutes and 1. 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose
    enhanced_encryption
    Safety Issue:
    No
  • tmax for ASA and SA
    date_rangeTime Frame:
    baseline (pre-dose) and 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 35, 40, 45, 50, 55 minutes and 1. 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Lambda(z) (terminal rate constant) for ASA and SA
    date_rangeTime Frame:
    baseline (pre-dose) and 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 35, 40, 45, 50, 55 minutes and 1. 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose
    enhanced_encryption
    Safety Issue:
    No

Trial design

An Open Label, Randomized, Two-Way Crossover Trial to assess the Bioequivalence of a single oral dose of a 1000 mg Fast Release Aspirin Tablet versus Two 500 mg Fast Release Aspirin Tablets in healthy male and female subjects
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Open Label
Assignment
Crossover Assignment
Trial Arms
2

Additional Information

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