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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. (Icicle)

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ClinicalTrials.gov Identifier: NCT02394093
Recruitment Status : Completed
First Posted : March 20, 2015
Last Update Posted : September 19, 2016
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pharmacology, Clinical Drug: Aspirin (Acetylsalicylic acid, BAYe4465) Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Crossover Pharmacokinetic Trial of Aspirin Dry Powder Versus Aspirin Tablets and Aspirin Effervescent Tablets in Healthy Adult Subjects
Study Start Date : February 2015
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
Experimental: Aspirin dry powder
500 mg Acetylsalicylic Acid (ASA) dry powder
Drug: Aspirin (Acetylsalicylic acid, BAYe4465)
One stick pack containing 500 mg acetylsalicylic acid dry powder

Active Comparator: Aspirin coated tablet
500 mg ASA coated tablet
Drug: Aspirin (Acetylsalicylic acid, BAYe4465)
One tablet containing 500 mg acetylsalicylic acid

Active Comparator: Aspirin effervescent tablet
500 mg ASA effervescent tablet
Drug: Aspirin (Acetylsalicylic acid, BAYe4465)
One effervescent tablet containing 500 mg acetylsalicylic acid




Primary Outcome Measures :
  1. Plasma concentration of Acetylsalicylic Acid (ASA) characterized by AUC0-t [ Time 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. ]
  2. Plasma concentration of Acetylsalicylic Acid (ASA) characterized by AUC0-∞ [ Time 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. ]
    AUC0-∞ : AUC from zero to infinity after single dose.

  3. Plasma concentration of Acetylsalicylic Acid (ASA) characterized by Cmax [ Time 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. ]
    Cmax: maximum drug concentration in plasma after single dose administration

  4. Plasma concentration of Acetylsalicylic Acid (ASA) characterized by tmax [ Time 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. ]
    tmax: time to reach maximum drug concentration in plasma after single (first) dose

  5. Plasma concentration of Acetylsalicylic Acid (ASA) characterized by λz (Kel) [ Time 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 ]
    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

  6. Plasma concentration of Acetylsalicylic Acid (ASA) characterized by t1/2 [ Time 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. ]
  7. Plasma concentration of Acetylsalicylic Acid (ASA) characterized by t lag [ Time 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. ]
    t lag : Lag-time (time delay between drug administration and first observed concentration above LLOQ (Lower limit of quantification)

  8. Plasma concentration of Acetylsalicylic Acid (ASA) characterized by Cmax/AUC0-∞ [ Time 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. ]
  9. Plasma concentration of Acetyl salicylic Acid (ASA) characterized by MRT [ Time 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. ]
    MRT :Mean residence time (for extravascular and iv bolus administration)

  10. Plasma concentration of Salicylic Acid (SA) characterized by AUC0-t [ Time 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. ]
  11. Plasma concentration of Salicylic Acid (SA) characterized by AUC0-∞ [ Time 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. ]
    AUC0-∞ : AUC from zero to infinity after single dose

  12. Plasma concentration of Salicylic Acid (SA) characterized by Cmax [ Time 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. ]
    Cmax: maximum drug concentration in plasma after single dose administration

  13. Plasma concentration of Salicylic Acid (SA) characterized by tmax [ Time 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. ]
    tmax: time to reach maximum drug concentration in plasma after single (first) dose

  14. Plasma concentration of Salicylic Acid (SA) characterized by λz (Kel) [ Time 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. ]
    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

  15. Plasma concentration of Salicylic Acid (SA) characterized by t1/2 [ Time 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. ]
  16. Plasma concentration of Salicylic Acid (SA) characterized by t lag [ Time 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. ]
    t lag : Lag-time (time delay between drug administration and first observed concentration above LLOQ

  17. Plasma concentration of Salicylic Acid (SA) characterized by Cmax/AUC0-∞ [ Time 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. ]
  18. Plasma concentration of Salicylic Acid (SA) characterized by MRT [ Time 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. ]
    MRT :Mean residence time (for extravascular and iv bolus administration)

  19. Plasma concentration of Acetylsalicylic Acid (ASA) characterized by AUC0-t /AUC0-∞ [ Time 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. ]
  20. Plasma concentration of Salicylic Acid (SA) characterized by AUC0-t /AUC0-∞ [ Time 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. ]

Secondary Outcome Measures :
  1. Number of participants with Adverse Events as measure of safety and tolerability [ Time Frame: Up to 5 weeks ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02394093


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

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02394093     History of Changes
Other Study ID Numbers: 17494
First Posted: March 20, 2015    Key Record Dates
Last Update Posted: September 19, 2016
Last Verified: September 2016

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
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics