Titre du document / Document title

SLI381 (adderall XR), a two-component, extended-release formulation of mixed amphetamine salts: Bioavailability of three test formulations and comparison of fasted, fed, and sprinkled administration

Auteur(s) / Author(s)

TULLOCH Simon J. ⁽¹⁾ ; YUXIN ZHANG ⁽²⁾ ; MCLEAR Angus ⁽³⁾ ; WOLF Kathleen N. ⁽¹⁾ ;

Affiliation(s) du ou des auteurs / Author(s) Affiliation(s)

⁽¹⁾ Department of Clinical Research, Shire Pharmaceutical Development Inc.,, Rockville, Maryland, ETATS-UNIS
⁽²⁾ Departments of, Biostatistics, Shire Pharmaceutical Development Inc., Rockville, Maryland, ETATS-UNIS
⁽³⁾ Department of Biopharmaceutics, Shire Pharmaceutical Development Inc., Rockville, Maryland, ETATS-UNIS

Résumé / Abstract

Study Objectives. To assess the bioavailability of three test formulations of a single dose of extended-release Adderall 20-mg capsules compared with two doses of immediate-release Adderall 10-mg tablets, and to assess the bioequivalence of a single 30-mg dose of the chosen extended-release Adderall formulation (designated as SLI381) administered in applesauce (sprinkled) and the same dose administered as an intact capsule with or without food. Design. Randomized, open-label, crossover study. Setting. Clinical research unit. Patients. Forty-one healthy adults. Interventions. Study A had four treatment sequences: three test formulations (A, B, and C) of a single dose of extended-release Adderall 20 mg, and two 10-mg doses of Adderall given 4 hours apart. Study B had three treatment sequences: a single dose of SLI381 30 mg as an intact capsule after overnight fast, an intact capsule after a high-fat breakfast, and the contents of a capsule sprinkled in 1 tablespoon of applesauce. Measurements and Main Results. The 20-mg test formulation A had comparable pharmacokinetic profiles and bioequivalence in rate and extent of drug absorption to Adderall 10 mg twice/day for both d- and 1-amphetamine. Formulations B and C had statistically significant differences from the reference drug in some pharmacokinetic parameters. A 30-mg dose of SL1381 showed no significant differences in rate and extent of absorption of d- and 1-amphetamine for fasted or sprinkled conditions compared with the high-fat meal condition. Conclusion. SL1381 20 mg/day is bioequivalent to Adderall 10 mg twice/day. SL1381 30 mg administered in applesauce is bioequivalent in terms of both rate and extent of absorption to the same dose administered as an intact capsule in both fasted and fed states.

Revue / Journal Title

Pharmacotherapy   ISSN 0277-0008   CODEN PHPYDQ 

Source / Source

2002, vol. 22, n^o11, pp. 1405-1415 [11 page(s) (article)] (29 ref.)

Langue / Language

Anglais

Editeur / Publisher

Pharmacotherapy, Boston, MA, ETATS-UNIS  (1981) (Revue)

Mots-clés anglais / English Keywords

Bioequivalence ; Controlled therapeutic trial ; Bioavailability ; Pharmacokinetics ; Human ; Comparative study ; Dissolution ; Food intake ; Fasting ; Oral administration ; Posology ; Application method ; Dosage form ; Immediate release form ; Controlled release form ; Psychotropic ; CNS stimulant ; Amphetamine derivatives ;

Mots-clés français / French Keywords

SLI 381 ; Bioéquivalence ; Essai thérapeutique contrôlé ; Biodisponibilité ; Pharmacocinétique ; Homme ; Etude comparative ; Dissolution ; Consommation alimentaire ; Jeûne alimentaire ; Voie orale ; Posologie ; Modalité traitement ; Forme pharmaceutique ; Forme libération immédiate ; Forme libération contrôlée ; Psychotrope ; Stimulant SNC ; Amphétamine dérivé ;

Mots-clés espagnols / Spanish Keywords

Bioequivalencia ; Ensayo terapéutico controlado ; Biodisponibilidad ; Farmacocinética ; Hombre ; Estudio comparativo ; Disolución ; Consumo alimenticio ; Ayuno alimenticio ; Vía oral ; Posología ; Modalidad tratamiento ; Forma farmacéutica ; Forma liberación inmediata ; Forma liberación controlada ; Psicotropo ; Estimulante SNC ; Amfetamina derivado ;

Localisation / Location

INIST-CNRS, Cote INIST : 19165, 35400010537869.0020