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Gary Ingenito
Catalyst Pharmaceuticals, Inc., Coral Gables, Florida, USA
Publications
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Research Article
Comparative Bioavailability of Two Tablet Formulations of Amifampridine with and without Food, and the Impact of Acetylator Status on the Pharmacokinetic Food Effect
Author(s): Keith D. Gallicano*, Gary Ingenito, Ardeshir Khadang and Peter Boldingh
Background: Previous research has not evaluated whether the two pharmaceutically non-equivalent tablet products containing amifampridine, Ruzurgi® (amifampridine) and Firdapse® (amifampridine phosphate), are bioequivalent under fasted and fed conditions, and if acetylator status influences the magnitude of the food effect. Therefore, we compared the bioavailability of amifampridine tablet 10 mg relative to that of amifampridine phosphate tablet 10 mg (base equivalent) in the fed state following consumption of a high-fat meal and in the fasted state, and investigated the effect of food intake on the pharmacokinetics of amifampridine and its inactive 3-N-acetyl metabolite in subjects evaluated for slow or rapid/intermediate N-acetyltransferase 2 (NAT2) metabolizer status. Methods: Twenty (20) hea.. View more»