Single-Dose Pharmacokinetics of Amphetamine Extended-Release Oral Suspension in Healthy Adults.

This single-dose pivotal study evaluated the pharmacokinetics of amphetamine extended-release oral suspension (AMPH EROS) under fasted and fed conditions and the relative bioavailability of AMPH EROS and immediate-release mixed amphetamine salts (IR MAS) in adults. This open-label, randomized, three-period, three-treatment, six-sequence crossover study enrolled 30 healthy adult participants who were randomly assigned to receive either 1 dose of AMPH EROS 18.8 mg under fed or fasted conditions or 30 mg of IR MAS under fasted conditions. Participants crossed over with a 7-day washout period between each of the three periods. Plasma samples were measured for , AUC, AUC, AUC, and AUC for comparative bioavailability. The geometric mean ratios for , AUC, and AUC were within the 90% confidence limits [80.0%, 125.0%] for comparable bioavailability. There was no food effect for AMPH EROS. Both the AMPH EROS and IR MAS formulations were generally well tolerated with no serious adverse events reported. The bioavailability of a single dose of AMPH EROS was comparable to two 15 mg doses of IR MAS, given 4 hr apart, with no food effect or safety concerns observed.