A Single-Dose, Two-Way Crossover, Open-Label Bioequivalence Study of an Amphetamine Extended-Release Oral Suspension in Healthy Adults. Issue 3 (February 2020)

• Record Type: Journal Article
• Authors: Sikes, Carolyn; Stark, Jeffrey G.; McMahen, Russ; Engelking, Dorothy
• Is Part Of: Journal of attention disorders. Volume 24:Issue 3(2020)
• Page Start: 414
• Page End: 419
• Publication Date: 2020-02
• Subjects: ADHD -- amphetamine -- psychopharmacology; Attention-deficit hyperactivity disorder -- Periodicals; Attention -- Periodicals; 616.8589
• DOI: 10.1177/1087054717743329
• Languages: English
• ISSNs: 1087-0547

Abstract

Objective: The purpose of this study was to compare the pharmacokinetics of a new extended-release amphetamine oral suspension (AMP XR-OS) with a standard extended-release mixed amphetamine salts product, Adderall XR®.Method : In this single-dose, open-label, randomized, two-period, two-treatment crossover study, 42 healthy adult volunteers received 15 mL of AMP XR-OS in one period and a 30 mg Adderall XR capsule in another period (both containing 18.8 mg of amphetamine base) under fasted conditions. Blood samples were analyzed for d - and l -amphetamine concentrations, and pharmacokinetic parameters Cmax, AUC0-5, AUC5-last, and AUCinf were calculated to determine bioequivalence. Safety was monitored throughout the study.Results : The 90% confidence intervals (CIs) for the log-transformed Cmax, AUC0-5, AUC5-last, and AUCinf fell within the accepted 80% to 125% range for establishing bioequivalence for d - and l -amphetamine. The most common adverse events were nausea and decreased appetite.Conclusion : AMP XR-OS is bioequivalent to Adderall XR in healthy adult participants.