Who is sponsoring NCT06655194?

NCT06655194 is sponsored by Bayer.

What drugs are being tested in NCT06655194?

Interventions in NCT06655194: Acetylsalicylic Acid (Aspirin, BAYE004465, UI1610477), Acetylsalicylic Acid (BAYE004465, UI1615160).

What condition does NCT06655194 study?

NCT06655194 studies Bioequivalence, Healthy Volunteers, Platelet Aggregation Inhibition.

Is NCT06655194 still recruiting?

NCT06655194 is currently completed. Last updated 15 April 2025.

Last reviewed 2025-04-15 · How we verify

NCT06655194

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 15 April 2025

What this trial tests

Phase 1 trial testing Acetylsalicylic Acid (Aspirin, BAYE004465, UI1610477) in Bioequivalence in 38 participants. Completed in 6 April 2025.

Timeline

26 February 2025

Primary endpoint
6 April 2025

6 April 2025

Quick facts

Lead sponsor	Bayer
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	other
Enrollment	38
Start date	26 February 2025
Primary completion	6 April 2025
Estimated completion	6 April 2025
Sites	1 location across Mexico

Drugs / interventions tested

Acetylsalicylic Acid (Aspirin, BAYE004465, UI1610477) — full drug profile →
Acetylsalicylic Acid (BAYE004465, UI1615160) — full drug profile →

Conditions studied

Bioequivalence — all drugs for Bioequivalence →
Healthy Volunteers — all drugs for Healthy Volunteers →
Platelet Aggregation Inhibition — all drugs for Platelet Aggregation Inhibition →

Sponsor

Bayer — full company profile →

Who can join

Adults 18 to 55, any sex, with Bioequivalence or Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Bioequivalence

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Trials by the same sponsor.

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NCT07192952 — A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Child · Phase 3 · not yet recruiting
NCT07450599 — A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Befo · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06655194 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bayer
Last refreshed: 15 April 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06655194.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing