BioequivalencePhase 1NCT06655194
A Study to Learn if There is a Difference in the Blood Levels of Acetylsalicylic Acid When Taken as Different Chewable Tablets on an Empty Stomach by Healthy Participants
A Phase 1 study testing Acetylsalicylic Acid (Aspirin, BAYE004465, UI1610477) and Acetylsalicylic Acid (BAYE004465, UI1615160) in people with Bioequivalence and Healthy Volunteers, run by Bayer at 1 site in Mexico.
Trial summary
In this study, researchers want to learn if 2 different forms of acetylsalicylic acid (ASA) chewable tablets will have the same effect in the body. For this, they compared the blood levels of a new form of ASA chewable tablet, which is manufactured at a different site, with an approved ASA chewable tablet, on an empty… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence, Healthy Volunteers, Platelet Aggregation Inhibition
- What is being tested?
- Acetylsalicylic Acid (Aspirin, BAYE004465, UI1610477) and Acetylsalicylic Acid (BAYE004465, UI1615160)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteMexico
- Study dates
- 26 Feb 2025to 6 Apr 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- Healthy, ambulatory male and female subjects between 18 to 55 years of age the health status will be assured by a complete physical examination, medical history, Electrocardiogram (ECG), vital sign measurement, and clinical laboratory testing.
- Subjects with a body weight of at least 50 kg and a Body Mass Index (BMI) between 18.0 to 27 kg/m2 according to Quetelet index.
- Subjects who have signed the authorization for clinical examinations (F-21 C) as well as the informed consent (F-07 C) before carrying out any procedure pertaining to the study.
- Subjects with legal capacity.
- Subjects understanding the nature, scope and risk/benefit of the trial and willing to adhere to the study procedures.
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- Subjects presenting the following ranges of physiologic parameters at the selection visit: systolic blood pressure (seated) for 90 to 139 mm/Hg, diastolic blood pressure from 60 to 89 mg/Hg, heart rate between 50 and 100 beats per minute and respiratory rate between 14 and 20 breaths per minute.
- ECG, Hematic Biometry, Urinalysis, Biochemical Profile in normal reference ranges.
- The participants (women) agree to take the necessary measures to avoid conception during the entire study and up to two weeks after its end.
- Female subjects must present a negative result for pregnancy.
- Subjects have to present a negative result for the antibodies of hepatitis B and hepatitis C.
- Subjects have to present a negative result with respect to Anti-human immunodeficiency virus (HIV) 1 and Anti-HIV 2 antibodies.
- Subjects have to present a negative result with respect to venereal disease research lab (RPR) test.
- Subjects have to present a negative result with respect to drug abuse (amphetamines, cocaine, cannabis, benzodiazepines and barbiturates) performed during the selection process/beginning of each study period.
- Subjects have to present a negative saliva alcohol test result at the beginning of each study period.
Who cannot join
- Subjects with any finding of physical examination (including blood pressure, heart and respiratory rate, ECG, and body temperature [forehead]) outside of normal ranges and of clinical relevance.
- History of asthma, urticaria or allergic-type reactions after taking aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs).
- Severe heart failure.
- Subjects with a history of chronic or recurrent cardiovascular, renal, hepatic, muscle, metabolic, immunological, gastrointestinal (especially history of bleeding, chronic gastritis or peptic ulcers) including constipation, neurological problems (especially history of epileptic seizures), endocrine, hematopoietic or any type of anemia, asthma, mental illness or other organic abnormalities.
- Subjects with a muscle injury within a range of 21 days prior to the start of the study.
- Subjects with a hereditary problem of galactose intolerance, lactase deficiency, or glucose-galactose mal-absorption.
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- Subjects who need any type of medication besides the study drug (exception: paracetamol up to 1 g/day).
- Subjects that have been exposed to drugs known as inductors or liver enzyme inhibitors or who have taken drugs which are capable of altering the urinary pH, like antacids with sodium bicarbonate, potassium citrate, diuretics, or any potentially toxic drugs within the 30 days prior to the beginning of the study.
- Subjects who have received any prescribed or over-the-counter (OTC) drug product, including vitamins and herbal remedies 30 days (or 7 half-lives) prior to the beginning of the study.
- Subjects who have been hospitalized for any disorder within seven months prior to the beginning of the study.
- Subjects who received investigational products within 90 days prior to the study.
- Subjects with a known hypersensitivity to any of the ingredients of the test or reference formulation.
- Subjects presenting a food allergy.
- Subjects who have consumed charcoal grilled nourishment 48 hours prior to the beginning of both study periods.
- Subjects consuming xanthine- and quinine-containing food and beverages and certain fruit juices such as grapefruit juice within 48 hours before investigational medicinal product (IMP) administration.
- Subjects having consumed alcohol within 48 hours before screening and within 12 hours before IMP administration (on Day -1 verified by saliva alcohol test).
- Smokers or currently consuming any type of tobacco product(s) including any smoking cessation nicotine-containing product within the previous three months (e.g., nicotine patch, nicotine gum).
- Subjects consuming xanthine excessively (more than 5 cups of coffee or equivalent beverages like energy drinks per day).
- Subjects who have donated or lost 450 mL or more blood within the 90 days prior to the beginning of the study.
- Subjects with a record of alcoholism and drug abuse, psycho-active substances or chronic medication during the previous 2 years.
- Subjects who require special diet for any reason, for example vegetarian diet.
- Subjects with any incapacity to understand the nature, purpose and possible consequences of the study.
- Subjects unwilling to follow study requirements and procedures.
- Subjects presenting a positive test for hepatitis B surface antigen test, anti hepatitis C, virus (Anti-HCV), or HIV-1/2 antibodies and HIV-1 p24-antigen.
- Subjects presenting a positive drug screen test or any history or suspicion of barbiturate, amphetamine, benzodiazepine, cocaine and cannabis.
- Subjects with any active disease, acute or chronic.
- Subjects with febrile or infectious illness within 1 week before screening.
- Subjects with any other disease or condition which could influence the metabolism of the drug (e.g., endocrine diseases).
- Subjects with any gastrointestinal complaints within 1 week before screening (gastrointestinal disorders including irritable bowel and gastrointestinal ulcer or bleeding).
- Subjects with a medical disorder, condition or history of such disorder or condition that could impair the subject's ability to participate or complete this trial in the opinion of the investigator.
- Subjects practicing sports excessively within 5 days before start of the treatment phase.
- Subjects with a complete body fungal infection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open Label, Semi-replicate Crossover Pharmacokinetic Study to Compare the Bioavailability of a Single Oral Dose of Aspirin® 81mg Quick Chews® and a Single Oral Dose of Acetylsalicylic Acid 81mg Chewable Tablets for Testing of Bioequivalence Under Fasting Conditions in Healthy Adult Subjects
In this study, researchers want to learn if 2 different forms of acetylsalicylic acid (ASA) chewable tablets will have the same effect in the body. For this, they compared the blood levels of a new form of ASA chewable tablet, which is manufactured at a different site, with an approved ASA chewable tablet, on an empty stomach in healthy participants. This is done as part of the regulatory requirement for the marketing approval of the new ASA chewable tablet.
The study treatment, ASA, is an antiplatelet drug. It works by making the blood thinner and stopping the blood from clotting.
Read more
In this study, participants will be healthy and will not benefit from taking ASA chewable tablets. However, the study will provide information on how the new ASA chewable tablet, which is manufactured at a different site, has an effect on the body.
The main purpose of this study is to compare blood levels of the new ASA chewable tablet with the approved ASA chewable tablet when taken as a single dose on an empty stomach.
For this, the researchers will analyze:
- Area under the curve (AUC): a measure of the total amount of ASA in participants' blood over time
- Maximum observed concentration (Cmax): the highest amount of ASA in participants' blood after a single dose without food
This study will have 3 treatment periods of 4 days each. In each period, participants will take either the new or approved ASA chewable tablet on an empty stomach according to the order assigned to them. The 2 treatment sequences in this study are:
New chewable tablet, approved chewable tablet, new chewable tablet
Approved chewable tablet, new chewable tablet, approved chewable tablet
Each participant will be in the study for around 7 weeks, which includes:
- a visit within 21 days of the first period to confirm if the participant can take part in the study
- hospital stay of around 2 days in each period, during which, participants will take their assigned treatment, and have blood tests to check for drug levels
- a gap of 1 week after taking the treatment in each period
During the study, the doctors and their study team will:
- measure the level of the study treatment by taking blood samples
- check participants' health by performing urine tests, checking vital signs and checking heart health using an electrocardiogram (ECG)
- ask the participants questions about how they are feeling and what adverse events they are having
An adverse event is any medical problem that a participant has during a study. The study doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment.
As this study is conducted in healthy participants who will not benefit from the treatment, access to the treatment after the study is not planned.
- Being tested
- Acetylsalicylic Acid (Aspirin, BAYE004465, UI1610477), Acetylsalicylic Acid (BAYE004465, UI1615160)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetylsalicylic Acid (Aspirin, BAYE004465, UI1610477)Drug
Chewable tablet, 81mg, oral
Acetylsalicylic Acid (BAYE004465, UI1615160)Drug
Chewable tablet, 81 mg, oral
| Study group | Role | What they receive |
|---|---|---|
| Comparator-test-comparator | Experimental | Participants will be randomly assigned to the treatment sequence "comparator-test-comparator" according to a computer-generated randomization list. Receives: Drug: Acetylsalicylic Acid (Aspirin, BAYE004465, UI1610477); Drug: Acetylsalicylic Acid (BAYE004465, UI1615160) |
| Test-comparator-test | Experimental | Participants will be randomly assigned to the treatment sequence "test-comparator-test" according to a computer-generated randomization list. Receives: Drug: Acetylsalicylic Acid (Aspirin, BAYE004465, UI1610477); Drug: Acetylsalicylic Acid (BAYE004465, UI1615160) |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC(0-tlast) of ASA
AUC(0-tlast): AUC from time 0 to the last data point > lower limit of quantitation (LLOQ)
Measured: Baseline (pre-dose) and at 0.083, 0.166, 0.250, 0.333, 0.416, 0.500, 0.583, 0.666, 0.750, 0.833, 0.916, 1.00, 1.25, 1.50, 2.00, 3.00, 4.00, 4.50, 5.00, 7.00, 9.00, 12.00 and 24.00 hours post dose in each treatment period
Cmax of ASA
Measured: Baseline (pre-dose) and at 0.083, 0.166, 0.250, 0.333, 0.416, 0.500, 0.583, 0.666, 0.750, 0.833, 0.916, 1.00, 1.25, 1.50, 2.00, 3.00, 4.00, 4.50, 5.00, 7.00, 9.00, 12.00 and 24.00 hours post dose in each treatment period
Secondary outcomes (6)
AUC of ASA and salicylic acid
Measured: Baseline (pre-dose) and at 0.083, 0.166, 0.250, 0.333, 0.416, 0.500, 0.583, 0.666, 0.750, 0.833, 0.916, 1.00, 1.25, 1.50, 2.00, 3.00, 4.00, 4.50, 5.00, 7.00, 9.00, 12.00 and 24.00 hours post dose in each treatment period
Ke of ASA and salicylic acid
Measured: Baseline (pre-dose) and at 0.083, 0.166, 0.250, 0.333, 0.416, 0.500, 0.583, 0.666, 0.750, 0.833, 0.916, 1.00, 1.25, 1.50, 2.00, 3.00, 4.00, 4.50, 5.00, 7.00, 9.00, 12.00 and 24.00 hours post dose in each treatment period
t1/2 of ASA and salicylic acid
t1/2: half-life associated with the terminal slope
Measured: Baseline (pre-dose) and at 0.083, 0.166, 0.250, 0.333, 0.416, 0.500, 0.583, 0.666, 0.750, 0.833, 0.916, 1.00, 1.25, 1.50, 2.00, 3.00, 4.00, 4.50, 5.00, 7.00, 9.00, 12.00 and 24.00 hours post dose in each treatment period
tmax of ASA and salicylic acid
tmax: time to reach Cmax (in case of two identical Cmax values, the first tmax will be used)
Measured: Baseline (pre-dose) and at 0.083, 0.166, 0.250, 0.333, 0.416, 0.500, 0.583, 0.666, 0.750, 0.833, 0.916, 1.00, 1.25, 1.50, 2.00, 3.00, 4.00, 4.50, 5.00, 7.00, 9.00, 12.00 and 24.00 hours post dose in each treatment period
Cmax of salicylic acid
Measured: Baseline (pre-dose) and at 0.083, 0.166, 0.250, 0.333, 0.416, 0.500, 0.583, 0.666, 0.750, 0.833, 0.916, 1.00, 1.25, 1.50, 2.00, 3.00, 4.00, 4.50, 5.00, 7.00, 9.00, 12.00 and 24.00 hours post dose in each treatment period
AUC(0-tlast) of salicylic acid
Measured: Baseline (pre-dose) and at 0.083, 0.166, 0.250, 0.333, 0.416, 0.500, 0.583, 0.666, 0.750, 0.833, 0.916, 1.00, 1.25, 1.50, 2.00, 3.00, 4.00, 4.50, 5.00, 7.00, 9.00, 12.00 and 24.00 hours post dose in each treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start26 Feb 2025
- Primary completion6 Apr 2025
- Study completion6 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioequivalenceStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06655194
- Sponsor's protocol ID
- 22518
- Status last verified
- Apr 2025
- First submitted
- 22 Oct 2024
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Semi-replicate Crossover Pharmacokinetic Study to Compare the Bioavailability of a Single Oral Dose of Aspirin® 81mg Quick Chews® and a Single Oral Dose of Acetylsalicylic Acid 81mg Chewable Tablets for Testing of Bioequivalence Under Fasting Conditions in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT06655194
- Acronym / sponsor ID
- 22518
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 26 Feb 2025 (actual)
- Primary completion
- 6 Apr 2025 (actual)
- Study completion
- 6 Apr 2025 (actual)
- First posted
- 23 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, researchers want to learn if 2 different forms of acetylsalicylic acid (ASA) chewable tablets will have the same effect in the body. For this, they compared the blood levels of a new form of ASA chewable tablet, which is manufactured at a different site, with an approved ASA chewable tablet, on an empty stomach in healthy participants. This is done as part of the regulatory requirement for the marketing approval of the new ASA chewable tablet.
The study treatment, ASA, is an antiplatelet drug. It works by making the blood thinner and stopping the blood from clotting.
In this study, participants will be healthy and will not benefit from taking ASA chewable tablets. However, the study will provide information on how the new ASA chewable tablet, which is manufactured at a different site, has an effect on the body.
The main purpose of this study is to compare blood levels of the new ASA chewable tablet with the approved ASA chewable tablet when taken as a single dose on an empty stomach.
For this, the researchers will analyze:
- Area under the curve (AUC): a measure of the total amount of ASA in participants' blood over time
- Maximum observed concentration (Cmax): the highest amount of ASA in participants' blood after a single dose without food
This study will have 3 treatment periods of 4 days each. In each period, participants will take either the new or approved ASA chewable tablet on an empty stomach according to the order assigned to them. The 2 treatment sequences in this study are:
New chewable tablet, approved chewable tablet, new chewable tablet
Approved chewable tablet, new chewable tablet, approved chewable tablet
Each participant will be in the study for around 7 weeks, which includes:
- a visit within 21 days of the first period to confirm if the participant can take part in the study
- hospital stay of around 2 days in each period, during which, participants will take their assigned treatment, and have blood tests to check for drug levels
- a gap of 1 week after taking the treatment in each period
During the study, the doctors and their study team will:
- measure the level of the study treatment by taking blood samples
- check participants' health by performing urine tests, checking vital signs and checking heart health using an electrocardiogram (ECG)
- ask the participants questions about how they are feeling and what adverse events they are having
An adverse event is any medical problem that a participant has during a study. The study doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment.
As this study is conducted in healthy participants who will not benefit from the treatment, access to the treatment after the study is not planned.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comparator-test-comparator | Experimental | Drug: Acetylsalicylic Acid (Aspirin, BAYE004465, UI1610477), Drug: Acetylsalicylic Acid (BAYE004465, UI1615160)Participants will be randomly assigned to the treatment sequence "comparator-test-comparator" according to a computer-generated randomization list. |
| Test-comparator-test | Experimental | Drug: Acetylsalicylic Acid (Aspirin, BAYE004465, UI1610477), Drug: Acetylsalicylic Acid (BAYE004465, UI1615160)Participants will be randomly assigned to the treatment sequence "test-comparator-test" according to a computer-generated randomization list. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- Healthy, ambulatory male and female subjects between 18 to 55 years of age the health status will be assured by a complete physical examination, medical history, Electrocardiogram (ECG), vital sign measurement, and clinical laboratory testing.
- Subjects with a body weight of at least 50 kg and a Body Mass Index (BMI) between 18.0 to 27 kg/m2 according to Quetelet index.
- Subjects who have signed the authorization for clinical examinations (F-21 C) as well as the informed consent (F-07 C) before carrying out any procedure pertaining to the study.
- Subjects with legal capacity.
Key exclusion criteria (32 listed)
- Subjects with any finding of physical examination (including blood pressure, heart and respiratory rate, ECG, and body temperature [forehead]) outside of normal ranges and of clinical relevance.
- History of asthma, urticaria or allergic-type reactions after taking aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs).
- Severe heart failure.
- Subjects with a history of chronic or recurrent cardiovascular, renal, hepatic, muscle, metabolic, immunological, gastrointestinal (especially history of bleeding, chronic gastritis or peptic ulcers) including constipation, neurological problems (especially history of epileptic seizures), endocrine, hematopoietic or any type of anemia, asthma, mental illness or other organic abnormalities.
- Subjects with a muscle injury within a range of 21 days prior to the start of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acetylsalicylic Acid (Aspirin, BAYE004465, UI1610477)Chewable tablet, 81mg, oral | Drug | Comparator-test-comparator, Test-comparator-test |
| Acetylsalicylic Acid (BAYE004465, UI1615160)Chewable tablet, 81 mg, oral | Drug | Comparator-test-comparator, Test-comparator-test |
Primary outcome
AUC(0-tlast) of ASA
Time frame: Baseline (pre-dose) and at 0.083, 0.166, 0.250, 0.333, 0.416, 0.500, 0.583, 0.666, 0.750, 0.833, 0.916, 1.00, 1.25, 1.50, 2.00, 3.00, 4.00, 4.50, 5.00, 7.00, 9.00, 12.00 and 24.00 hours post dose in each treatment period
AUC(0-tlast): AUC from time 0 to the last data point > lower limit of quantitation (LLOQ)
Cmax of ASA
Time frame: Baseline (pre-dose) and at 0.083, 0.166, 0.250, 0.333, 0.416, 0.500, 0.583, 0.666, 0.750, 0.833, 0.916, 1.00, 1.25, 1.50, 2.00, 3.00, 4.00, 4.50, 5.00, 7.00, 9.00, 12.00 and 24.00 hours post dose in each treatment period
6 secondary outcomes
AUC of ASA and salicylic acid
Time frame: Baseline (pre-dose) and at 0.083, 0.166, 0.250, 0.333, 0.416, 0.500, 0.583, 0.666, 0.750, 0.833, 0.916, 1.00, 1.25, 1.50, 2.00, 3.00, 4.00, 4.50, 5.00, 7.00, 9.00, 12.00 and 24.00 hours post dose in each treatment period
Ke of ASA and salicylic acid
Time frame: Baseline (pre-dose) and at 0.083, 0.166, 0.250, 0.333, 0.416, 0.500, 0.583, 0.666, 0.750, 0.833, 0.916, 1.00, 1.25, 1.50, 2.00, 3.00, 4.00, 4.50, 5.00, 7.00, 9.00, 12.00 and 24.00 hours post dose in each treatment period
t1/2 of ASA and salicylic acid
Time frame: Baseline (pre-dose) and at 0.083, 0.166, 0.250, 0.333, 0.416, 0.500, 0.583, 0.666, 0.750, 0.833, 0.916, 1.00, 1.25, 1.50, 2.00, 3.00, 4.00, 4.50, 5.00, 7.00, 9.00, 12.00 and 24.00 hours post dose in each treatment period
tmax of ASA and salicylic acid
Time frame: Baseline (pre-dose) and at 0.083, 0.166, 0.250, 0.333, 0.416, 0.500, 0.583, 0.666, 0.750, 0.833, 0.916, 1.00, 1.25, 1.50, 2.00, 3.00, 4.00, 4.50, 5.00, 7.00, 9.00, 12.00 and 24.00 hours post dose in each treatment period
Cmax of salicylic acid
Time frame: Baseline (pre-dose) and at 0.083, 0.166, 0.250, 0.333, 0.416, 0.500, 0.583, 0.666, 0.750, 0.833, 0.916, 1.00, 1.25, 1.50, 2.00, 3.00, 4.00, 4.50, 5.00, 7.00, 9.00, 12.00 and 24.00 hours post dose in each treatment period
AUC(0-tlast) of salicylic acid
Time frame: Baseline (pre-dose) and at 0.083, 0.166, 0.250, 0.333, 0.416, 0.500, 0.583, 0.666, 0.750, 0.833, 0.916, 1.00, 1.25, 1.50, 2.00, 3.00, 4.00, 4.50, 5.00, 7.00, 9.00, 12.00 and 24.00 hours post dose in each treatment period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Acetylsalicylic Acid (Aspirin, BAYE004465, UI1610477) and Acetylsalicylic Acid (BAYE004465, UI1615160) in people with Bioequivalence and Healthy Volunteers, run by Bayer at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC(0-tlast) of ASA (time frame: Baseline (pre-dose) and at 0.083, 0.166, 0.250, 0.333, 0.416, 0.500, 0.583, 0.666, 0.750, 0.833, 0.916, 1.00, 1.25, 1.50, 2.00, 3.00, 4.00, 4.50, 5.00, 7.00, 9.00, 12.00 and 24.00 hours post dose in each treatment period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2025.