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A single-dose, comparative bioavailability study comparing amphetamine extended-release oral suspension with extended-release mixed amphetamine salts capsules

Published online by Cambridge University Press:  03 December 2020

Antonio Pardo ,
Mohammed Bouhajib ,
Thomas R. King Open the ORCID record for Thomas R. King [Opens in a new window] ,
Eman Rafla  and
Judith C. Kando
Antonio Pardo
Affiliation:
Tris Pharma, Inc., Clinical and Medical Affairs, Monmouth Junction, NJ, USA
Mohammed Bouhajib
Affiliation:
Pharma Medica Research Institute, Toronto, ON, Canada
Thomas R. King*
Affiliation:
Tris Pharma, Inc., Clinical and Medical Affairs, Monmouth Junction, NJ, USA
Eman Rafla
Affiliation:
Tris Pharma, Inc., Clinical and Medical Affairs, Monmouth Junction, NJ, USA
Judith C. Kando
Affiliation:
Tris Pharma, Inc., Clinical and Medical Affairs, Monmouth Junction, NJ, USA
*
*Author for correspondence: Thomas R. King Email: tking@trispharma.com
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Abstract

Background

To evaluate the relative bioavailability of a single dose of amphetamine extended-release oral suspension (AMPH EROS) compared with a single dose of extended-release mixed amphetamine salts (ER MAS) in healthy, fasted adult subjects.

Methods

The study population consisted of healthy adult volunteers. The study drug used in this study was 7.5 mL of 2.5 mg/mL AMPH EROS equivalent to 18.8 mg of amphetamine base administered after an overnight fast of at least 10 hours. AMPH EROS comprises a 3.2:1 enantiomeric ratio of d-amphetamine to l-amphetamine. The reference product was one 30 mg ER MAS capsule (equivalent to 18.8 mg of amphetamine base). Relative bioavailability between the products was determined by a statistical comparison of the area under the curve and maximum concentration (Cmax) for d-amphetamine and l-amphetamine. PK (PK) blood samples were collected prior to dosing (0-hour) and at 1, 2, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 12, 14, 16, 24, 36, 48, and 60 hours after drug administration, totaling 20 samples in each period.

Results

The mean subject age was 35.0 (standard deviation ±8) years, and the overall study population comprised 19 (63.3%) males and 11 (36.7%) females. The contrasts for geometric mean ratios for all assessed PK parameters (for both l- and d-amphetamine) between the test article AMPH EROS and reference product ER MAS fell within the prescribed 80% to 125% limits.

Conclusions

The overall PK profile of single-dose AMPH EROS 7.5 mL was found to be comparable with a single dose of oral ER MAS 30 mg.

Keywords

ADHDstimulantamphetaminepharmacokinetic
Type
Original Research
Information
CNS Spectrums , Volume 27 , Issue 3 , June 2022 , pp. 309 - 314
Copyright
© The Author(s), 2020. Published by Cambridge University Press

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