This is a pilot bioequivalence study. It is a randomized, open-label, single-dose, crossover study. The primary objective of this study is to preliminarily evaluate the pharmacokinetic parameters and their variability of the test formulation versus the reference formulation following a single oral dose under fed conditions.
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Maximum plasma concentration (Cmax)
Timeframe: Pre-dose and at multiple timepoints post-dose up to 72 hours
Area Under the Plasma Concentration-Time Curve from time zero to the last measurable concentration (AUC0-last)
Timeframe: Pre-dose and at multiple timepoints post-dose up to 72 hours
Area Under the Plasma Concentration-Time Curve from time zero to infinity (AUC0-∞)
Timeframe: Pre-dose and at multiple timepoints post-dose up to 72 hours