Bioequivalence of two formulations of 750 mg levetiracetam extended-release coated tablets in healthy volunteers under fasting and fed conditions
DOI:
https://doi.org/10.30968/jhphs.2026.171.1366Abstract
Objective: To evaluate the bioequivalence of the two formulations of Eurofarma’s Levetiracetam 750 mg Extended Release Coated Tablets (Test Product [T]) against Keppra XR (Reference Product [R]) in healthy adults under fasting and fed conditions. Methods: The studies were designed as open, randomized, balanced, two treatments, two-period, single dose, crossover under fasting and fed condition with seven days washout interval. The assigned subjects were given test tablets and reference tablets in each period orally at a dose of 750 mg under fasting and fed conditions. Each study involved 32 subjects. In both the studies under fasting and fed conditions, the major pharmacokinetic parameters were calculated by SAS® Software 9.4 and the bioequivalence was evaluated. Results: For bioequivalence evaluation a total of 31 subjects completed the fasting study, and 29 subjects completed the fed study. The 90% confidence intervals for the geometric mean ratios of Levetiracetam area under the curve (AUC0-T and AUC0-∞) and maximum plasma concentration (Cmax ) were within the established bioequivalence limits of 80% to 125%. A total of three adverse events were reported during the conduct of the two studies, with one event possibly related to the study medication and the other two considered unrelated. All adverse events were mild to moderate in severity and did not significantly impact the participants’ quality of life. No serious adverse events were reported. Conclusion: It can be concluded that the two formulations can be used interchangeably.
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