Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 1:39 AM
Study NCT ID:
NCT06655194
Status:
COMPLETED
Last Update Posted:
2025-04-15
First Post:
2024-10-22
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Bayer
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: