check_circleStudy Completed

Pharmacology, Clinical

Bayer Identifier:

17494

ClinicalTrials.gov Identifier:

NCT02394093

EudraCT Number:

Not Available

EU CT Number:

Not Available
To evaluate the bioavailability of a single oral dose of the Acetylsalicylic Acid containing dry powder 500 mg in comparison to the bioavailability of a single oral dose of aspirin tablets and aspirin effervescent tablets in healthy adults.

Trial purpose

To evaluate the bioavailability of a single oral dose of the Acetylsalicylic Acid containing dry powder 500 mg in comparison to the bioavailability of a single oral dose of aspirin tablets and aspirin effervescent tablets in healthy adults.

Key Participants Requirements

Sex

Both

Age

18 - 55 Years
  • - Healthy ,male and female subjects 18 to 55 years of age, inclusive
    - 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 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.

  • - 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 1,2 and 3
    - Females who are pregnant or lactating

Trial summary

Enrollment Goal
30
Trial Dates
February 2015 - March 2015
Phase
Phase 1
Could I Receive a placebo
No
Products
Aspirin (Acetylsalicylic Acid, BAYE4465)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Hackensack, 07601, United States

Primary Outcome

  • Plasma concentration of Acetylsalicylic Acid (ASA) characterized by AUC0-t
    date_rangeTime Frame:
    baseline (pre-dose), 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 32.5, 35, 37.5, 40, 42.5, 45, 50, 55 minutes and 1, 1.25, 1.5, 1.75, 2, 3, 4, 5, 7, 9, 12 and 24 hours post-dose.
    enhanced_encryption
    Safety Issue:
    No
  • Plasma concentration of Acetylsalicylic Acid (ASA) characterized by AUC0-∞
    AUC0-∞ : AUC from zero to infinity after single dose.
    date_rangeTime Frame:
    baseline (pre-dose), 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 32.5, 35, 37.5, 40, 42.5, 45, 50, 55 minutes and 1, 1.25, 1.5, 1.75, 2, 3, 4, 5, 7, 9, 12 and 24 hours post-dose.
    enhanced_encryption
    Safety Issue:
    No
  • Plasma concentration of Acetylsalicylic Acid (ASA) characterized by Cmax
    Cmax: maximum drug concentration in plasma after single dose administration
    date_rangeTime Frame:
    baseline (pre-dose), 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 32.5, 35, 37.5, 40, 42.5, 45, 50, 55 minutes and 1, 1.25, 1.5, 1.75, 2, 3, 4, 5, 7, 9, 12 and 24 hours post-dose.
    enhanced_encryption
    Safety Issue:
    No
  • Plasma concentration of Acetylsalicylic Acid (ASA) characterized by tmax
    tmax: time to reach maximum drug concentration in plasma after single (first) dose
    date_rangeTime Frame:
    baseline (pre-dose), 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 32.5, 35, 37.5, 40, 42.5, 45, 50, 55 minutes and 1, 1.25, 1.5, 1.75, 2, 3, 4, 5, 7, 9, 12 and 24 hours post-dose.
    enhanced_encryption
    Safety Issue:
    No
  • Plasma concentration of Acetylsalicylic Acid (ASA) characterized by λz (Kel)
    λz (Kel) : Apparent terminal rate constant, calculated from the slope of a log-linear regression of the unweighted data considering the last concentration-time points > LLOQ
    date_rangeTime Frame:
    baseline (pre-dose), 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 32.5, 35, 37.5, 40, 42.5, 45, 50, 55 minutes and 1, 1.25, 1.5, 1.75, 2, 3, 4, 5, 7, 9, 12 and 24 hours post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Plasma concentration of Acetylsalicylic Acid (ASA) characterized by t1/2
    date_rangeTime Frame:
    baseline (pre-dose), 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 32.5, 35, 37.5, 40, 42.5, 45, 50, 55 minutes and 1, 1.25, 1.5, 1.75, 2, 3, 4, 5, 7, 9, 12 and 24 hours post-dose.
    enhanced_encryption
    Safety Issue:
    No
  • Plasma concentration of Acetylsalicylic Acid (ASA) characterized by t lag
    t lag : Lag-time (time delay between drug administration and first observed concentration above LLOQ (Lower limit of quantification)
    date_rangeTime Frame:
    baseline (pre-dose), 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 32.5, 35, 37.5, 40, 42.5, 45, 50, 55 minutes and 1, 1.25, 1.5, 1.75, 2, 3, 4, 5, 7, 9, 12 and 24 hours post-dose.
    enhanced_encryption
    Safety Issue:
    No
  • Plasma concentration of Acetylsalicylic Acid (ASA) characterized by Cmax/AUC0-∞
    date_rangeTime Frame:
    baseline (pre-dose), 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 32.5, 35, 37.5, 40, 42.5, 45, 50, 55 minutes and 1, 1.25, 1.5, 1.75, 2, 3, 4, 5, 7, 9, 12 and 24 hours post-dose.
    enhanced_encryption
    Safety Issue:
    No
  • Plasma concentration of Acetyl salicylic Acid (ASA) characterized by MRT
    MRT :Mean residence time (for extravascular and iv bolus administration)
    date_rangeTime Frame:
    baseline (pre-dose), 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 32.5, 35, 37.5, 40, 42.5, 45, 50, 55 minutes and 1, 1.25, 1.5, 1.75, 2, 3, 4, 5, 7, 9, 12 and 24 hours post-dose.
    enhanced_encryption
    Safety Issue:
    No
  • Plasma concentration of Salicylic Acid (SA) characterized by AUC0-t
    date_rangeTime Frame:
    baseline (pre-dose), 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 32.5, 35, 37.5, 40, 42.5, 45, 50, 55 minutes and 1, 1.25, 1.5, 1.75, 2, 3, 4, 5, 7, 9, 12 and 24 hours post-dose.
    enhanced_encryption
    Safety Issue:
    No
  • Plasma concentration of Salicylic Acid (SA) characterized by AUC0-∞
    AUC0-∞ : AUC from zero to infinity after single dose
    date_rangeTime Frame:
    baseline (pre-dose), 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 32.5, 35, 37.5, 40, 42.5, 45, 50, 55 minutes and 1, 1.25, 1.5, 1.75, 2, 3, 4, 5, 7, 9, 12 and 24 hours post-dose.
    enhanced_encryption
    Safety Issue:
    No
  • Plasma concentration of Salicylic Acid (SA) characterized by Cmax
    Cmax: maximum drug concentration in plasma after single dose administration
    date_rangeTime Frame:
    baseline (pre-dose), 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 32.5, 35, 37.5, 40, 42.5, 45, 50, 55 minutes and 1, 1.25, 1.5, 1.75, 2, 3, 4, 5, 7, 9, 12 and 24 hours post-dose.
    enhanced_encryption
    Safety Issue:
    No
  • Plasma concentration of Salicylic Acid (SA) characterized by tmax
    tmax: time to reach maximum drug concentration in plasma after single (first) dose
    date_rangeTime Frame:
    baseline (pre-dose), 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 32.5, 35, 37.5, 40, 42.5, 45, 50, 55 minutes and 1, 1.25, 1.5, 1.75, 2, 3, 4, 5, 7, 9, 12 and 24 hours post-dose.
    enhanced_encryption
    Safety Issue:
    No
  • Plasma concentration of Salicylic Acid (SA) characterized by λz (Kel)
    λz (Kel) : Apparent terminal rate constant, calculated from the slope of a log-linear regression of the unweighted data considering the last concentration-time points > LLOQ
    date_rangeTime Frame:
    baseline (pre-dose), 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 32.5, 35, 37.5, 40, 42.5, 45, 50, 55 minutes and 1, 1.25, 1.5, 1.75, 2, 3, 4, 5, 7, 9, 12 and 24 hours post-dose.
    enhanced_encryption
    Safety Issue:
    No
  • Plasma concentration of Salicylic Acid (SA) characterized by t1/2
    date_rangeTime Frame:
    baseline (pre-dose), 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 32.5, 35, 37.5, 40, 42.5, 45, 50, 55 minutes and 1, 1.25, 1.5, 1.75, 2, 3, 4, 5, 7, 9, 12 and 24 hours post-dose.
    enhanced_encryption
    Safety Issue:
    No
  • Plasma concentration of Salicylic Acid (SA) characterized by t lag
    t lag : Lag-time (time delay between drug administration and first observed concentration above LLOQ
    date_rangeTime Frame:
    baseline (pre-dose), 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 32.5, 35, 37.5, 40, 42.5, 45, 50, 55 minutes and 1, 1.25, 1.5, 1.75, 2, 3, 4, 5, 7, 9, 12 and 24 hours post-dose.
    enhanced_encryption
    Safety Issue:
    No
  • Plasma concentration of Salicylic Acid (SA) characterized by Cmax/AUC0-∞
    date_rangeTime Frame:
    baseline (pre-dose), 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 32.5, 35, 37.5, 40, 42.5, 45, 50, 55 minutes and 1, 1.25, 1.5, 1.75, 2, 3, 4, 5, 7, 9, 12 and 24 hours post-dose.
    enhanced_encryption
    Safety Issue:
    No
  • Plasma concentration of Salicylic Acid (SA) characterized by MRT
    MRT :Mean residence time (for extravascular and iv bolus administration)
    date_rangeTime Frame:
    baseline (pre-dose), 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 32.5, 35, 37.5, 40, 42.5, 45, 50, 55 minutes and 1, 1.25, 1.5, 1.75, 2, 3, 4, 5, 7, 9, 12 and 24 hours post-dose.
    enhanced_encryption
    Safety Issue:
    No
  • Plasma concentration of Acetylsalicylic Acid (ASA) characterized by AUC0-t /AUC0-∞
    date_rangeTime Frame:
    baseline (pre-dose), 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 32.5, 35, 37.5, 40, 42.5, 45, 50, 55 minutes and 1, 1.25, 1.5, 1.75, 2, 3, 4, 5, 7, 9, 12 and 24 hours post-dose.
    enhanced_encryption
    Safety Issue:
    No
  • Plasma concentration of Salicylic Acid (SA) characterized by AUC0-t /AUC0-∞
    date_rangeTime Frame:
    baseline (pre-dose), 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, 30, 32.5, 35, 37.5, 40, 42.5, 45, 50, 55 minutes and 1, 1.25, 1.5, 1.75, 2, 3, 4, 5, 7, 9, 12 and 24 hours post-dose.
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Number of participants with Adverse Events as measure of safety and tolerability
    date_rangeTime Frame:
    Up to 5 weeks
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

An Open Label Crossover Pharmacokinetic Trial of Aspirin Dry Powder versus Aspirin Tablets and Aspirin Effervescent Tablets in Healthy Adult Subjects
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Open Label
Assignment
Crossover Assignment
Trial Arms
3

Additional Information

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