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Artigos Científicos

sexta-feira, 01 dezembro 2017 14:15

A Single-Dose, Two-Way Crossover, Open-Label Bioequivalence Study of an Amphetamine Extended-Release Oral Suspension in Healthy Adults

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Carolyn Sikes1, Jeffrey G. Stark2, Russ McMahen1, Dorothy Engelking1

1
Neos Therapeutics Inc., Grand Prairie, TX, USA
2
Worldwide Clinical Trials, Austin, TX, USA

Journal of Attention Disorders: SAGE Journals

December 1, 2017


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.


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