Single-Dose Pharmacokinetics of Amphetamine Extended-Release Oral Suspension in Healthy Adults.
J Atten Disord
; 25(6): 803-808, 2021 04.
Article
em En
| MEDLINE
| ID: mdl-31027435
ABSTRACT
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.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Transtorno do Deficit de Atenção com Hiperatividade
/
Anfetamina
Tipo de estudo:
Clinical_trials
Limite:
Adult
/
Humans
Idioma:
En
Revista:
J Atten Disord
Ano de publicação:
2021
Tipo de documento:
Article