CompletedNCT02394093IcicleUpdated Sep 19, 2016

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.

A Phase 1 interventional study of Aspirin (Acetylsalicylic acid, BAYe4465) and Aspirin (Acetylsalicylic acid, BAYe4465) in Pharmacology, Clinical, sponsored by Bayer. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-09-19.

Sponsored by Bayer · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 30
Allocation: Randomized
Ages: 18 Years to 55 Years
Sex: All

Study 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.

Conditions studied

Pharmacology, Clinical

In context

Lead sponsor

Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.

Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 30 participants (actual)

Study arms

Experimental
Aspirin dry powder
500 mg Acetylsalicylic Acid (ASA) dry powder
Drug: Aspirin (Acetylsalicylic acid, BAYe4465)
Active comparator
Aspirin coated tablet
500 mg ASA coated tablet
Drug: Aspirin (Acetylsalicylic acid, BAYe4465)
Active comparator
Aspirin effervescent tablet
500 mg ASA effervescent tablet
Drug: Aspirin (Acetylsalicylic acid, BAYe4465)

Interventions

DrugAspirin (Acetylsalicylic acid, BAYe4465)
One stick pack containing 500 mg acetylsalicylic acid dry powder
DrugAspirin (Acetylsalicylic acid, BAYe4465)
One tablet containing 500 mg acetylsalicylic acid
DrugAspirin (Acetylsalicylic acid, BAYe4465)
One effervescent tablet containing 500 mg acetylsalicylic acid

What researchers measure

Primary outcomes

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.
Plasma concentration of Acetylsalicylic Acid (ASA) characterized by AUC0-∞
AUC0-∞ : AUC from zero to infinity after single dose.
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.
Plasma concentration of Acetylsalicylic Acid (ASA) characterized by Cmax
Cmax: maximum drug concentration in plasma after single dose administration
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.
Plasma concentration of Acetylsalicylic Acid (ASA) characterized by tmax
tmax: time to reach maximum drug concentration in plasma after single (first) dose
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.
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
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
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.
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)
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.
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.
Plasma concentration of Acetyl salicylic Acid (ASA) characterized by MRT
MRT :Mean residence time (for extravascular and iv bolus administration)
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.
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.
Plasma concentration of Salicylic Acid (SA) characterized by AUC0-∞
AUC0-∞ : AUC from zero to infinity after single dose
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.
Plasma concentration of Salicylic Acid (SA) characterized by Cmax
Cmax: maximum drug concentration in plasma after single dose administration
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.
Plasma concentration of Salicylic Acid (SA) characterized by tmax
tmax: time to reach maximum drug concentration in plasma after single (first) dose
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.
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
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.
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.
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
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.
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.
Plasma concentration of Salicylic Acid (SA) characterized by MRT
MRT :Mean residence time (for extravascular and iv bolus administration)
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.
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.
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 outcomes

Number of participants with Adverse Events as measure of safety and tolerability
Time frame: Up to 5 weeks

Study locations

1 site

Hackensack, New Jersey 07601, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 19, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02394093
Lead sponsor: Bayer
Responsible party: Sponsor
First posted: Mar 20, 2015
Start date: Feb 2015
Primary completion: Mar 2015
Completion: Mar 2015
Last update: Sep 19, 2016

Study contacts

Bayer Study Director

study director · Bayer

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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