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

• Published in: Journal of attention disorders 2021-04, Vol.25 (6), p.803-808
• Main Authors: Herman, Barry K., Bouhajib, Mohammed, King, Thomas R., Kando, Judith C., Pardo, Antonio
• Format: Article
• Language: English
• Subjects: Administration, Oral; Adult; Amphetamine - pharmacokinetics; Amphetamine - therapeutic use; Attention Deficit Disorder with Hyperactivity - drug therapy; Biological Availability; Cross-Over Studies; Delayed-Action Preparations - pharmacokinetics; Humans
• ISSN: 1087-0547; 1557-1246
• DOI: 10.1177/1087054719841131

Purpose: 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. Methods: 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 Cmax, AUC0-t, AUC0-5, AUC5-t, and AUC0-∞ for comparative bioavailability. Results: The geometric mean ratios for Cmax, AUC0-t, and AUC0-∞ 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. Conclusions: 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.