Key result
An 81-mg re-formulation of acetylsalicylic acid was bioequivalent to the reference formulation in fed healthy subjects, with significant sex-related differences in disposition observed (p<0.001).
Why the study?
To compare the bioavailability between a test re-formulation and a reference acetylsalicylic acid formulation in healthy subjects under fed conditions.
Is a test formulation of 81-mg acetylsalicylic acid bioequivalent to a reference formulation in fed healthy subjects?
RCT (n=48)
Open-label
randomized
No
Is a test formulation of 81-mg acetylsalicylic acid bioequivalent to a reference formulation in fed healthy subjects?
A new 81-mg coated tablet formulation of acetylsalicylic acid is bioequivalent to the reference formulation in fed healthy subjects.
Supports bioequivalence of the re-formulation to Ecasil-81 under fed conditions in healthy volunteers; leaves open translation to patients on chronic low-dose therapy.
OBJECTIVE: To perform a comparative bioavailability study between a test (re-formulation) and a reference acetylsalicylic acid formulation (Ecasil-81, 81 mg coated tablet) in healthy subjects under fed condition. MATERIALS AND METHODS: Healthy subjects (n = 48) were included in this monocentric, open-label, randomized, two-way crossover pharmacokinetic study. They received a single 81-mg oral dose of a test or a reference formulation of acetylsalicylic acid under fed condition, with a 7-day washout period between the treatments. Blood samples were collected over a period of 36 hours. The salicylic acid plasma concentration was measured by liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS). Pharmacokinetic analysis was performed using WinNonlin software. RESULTS: values (p < 0.001) than men. The clinical and laboratory exams did not show significant alterations. CONCLUSION: The re-formulation is bioequivalent to the reference formulation regarding the absorption extent and rate in fed healthy subjects. The administration of acetylsalicylic acid with food decreased its bioavailability. Moreover, differences in salicylic acid disposition related to sex were observed. The treatments were well tolerated by the investigated subjects.
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Dolores et al. (2020) conducted an RCT in Healthy subjects (n=48). Acetylsalicylic acid re-formulation vs. Reference acetylsalicylic acid formulation (Ecasil-81) was evaluated on Bioavailability (absorption extent and rate). An 81-mg re-formulation of acetylsalicylic acid was bioequivalent to the reference formulation in fed healthy subjects, with significant sex-related differences in disposition observed (p<0.001).
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