Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06655194
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-22
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:
None
Organization:
None
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:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None