Key result
A novel oral aspirin solution provided more rapid exposure to higher plasma concentration levels of acetylsalicylic acid than chewing a solid tablet, achieving 74% greater concentrations at 3 minutes under fasting conditions.
Why the study?
The study was conducted to assess the pharmacokinetic profiles of acetylsalicylic acid and salicylic acid following administration of two different aspirin formulations under fasting and fed conditions.
Does a novel oral aspirin solution provide more rapid exposure to acetylsalicylic acid compared to a chewed aspirin tablet in healthy subjects?
RCT (n=24)
Open-label
1:1 ratio
No
Does a novel oral aspirin solution provide more rapid exposure to acetylsalicylic acid compared to a chewed aspirin tablet in healthy subjects?
Effect estimate: 74% greater
Absolute Event Rate: 356% vs 204%
A novel oral aspirin solution provides more rapid exposure to higher plasma concentrations of acetylsalicylic acid than chewing a solid tablet, suggesting potential benefit for early administration in suspected acute myocardial infarction.
Supports earlier antiplatelet action in suspected acute MI; extends RCT pharmacokinetic data to fed conditions.
OBJECTIVES: The primary objective of this study was to assess the pharmacokinetic profiles of acetylsalicylic acid (ASA) and salicylic acid (SA) after administration of two different formulations of aspirin under fasting and fed conditions. MATERIALS AND METHODS: The study was a randomized, open-label, parallel-group, 2-arm crossover study conducted at a single center. Healthy subjects were randomized to receive 300 mg of aspirin in either a 15-mL oral solution (pre-packaged vial containing powder and solvent that are combined at the time of administration) or a single solid tablet to be chewed and swallowed with 150 mL of water. Treatment visits were separated by a 10-day wash-out period. RESULTS: , with the oral solutions was 179,116.7 min.ng/mL compared to 164,704.3 min.ng/mL with the chewed tablet. CONCLUSION: This phase 1 study showed that use of an aspirin oral solution provided more rapid exposure to higher plasma concentration levels of ASA and SA than chewing a solid tablet.
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Atar et al. (2022) conducted an RCT in Healthy subjects (n=24). Novel oral aspirin solution vs. Chewed aspirin tablet was evaluated on Mean plasma acetylsalicylic acid (ASA) concentration at 3 minutes (fasting state) in ng/mL (74% greater). A novel oral aspirin solution provided more rapid exposure to higher plasma concentration levels of acetylsalicylic acid than chewing a solid tablet, achieving 74% greater concentrations at 3 minutes under fasting conditions.
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