MedTrace Logo

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

NCT06655194 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2025-04-15

No results posted yet for this study

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 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.

Conditions

  • Bioequivalence
  • Healthy Volunteers
  • Platelet Aggregation Inhibition

Interventions

DRUG

Acetylsalicylic Acid (Aspirin, BAYE004465, UI1610477)

Chewable tablet, 81mg, oral

DRUG

Acetylsalicylic Acid (BAYE004465, UI1615160)

Chewable tablet, 81 mg, oral

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-02-26
Primary Completion
2025-04-06
Completion
2025-04-06

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06655194 on ClinicalTrials.gov