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.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  Randomized, open-label, crossover study.
  
  
  METHODS
  Clinical research unit.
  
  
  METHODS
  Forty-one healthy adults.
  
  
  METHODS
  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.
  
  
  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 l-amphetamine. Formulations B and C had statistically significant differences from the reference drug in some pharmacokinetic parameters. A 30-mg dose of SLI381 showed no significant differences in rate and extent of absorption of d- and l-amphetamine for fasted or sprinkled conditions compared with the high-fat meal condition.
  
  
  CONCLUSIONS
  SLI381 20 mg/day is bioequivalent to Adderall 10 mg twice/day. SLI381 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.
authors.affiliation: Department of Clinical Research, Shire Pharmaceutical Development Inc., Rockville, Maryland 20850-1801, USA.
authors.forename: Simon J
authors.initials: SJ
authors.lastname: Tulloch
authors.forename: Yuxin
authors.initials: Y
authors.lastname: Zhang
authors.forename: Angus
authors.initials: A
authors.lastname: McLean
authors.forename: Kathleen N
authors.initials: KN
authors.lastname: Wolf
mesh_terms: D000328:Adult; D000661:Amphetamine / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D000662:Amphetamines / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D000704:Analysis of Variance; D019540:Area Under Curve; D001682:Biological Availability; D002626:Chemistry, Pharmaceutical; D016001:Confidence Intervals; D018592:Cross-Over Studies; D003692:Delayed-Action Preparations / Q000008:administration & dosage / Q000493:pharmacokinetics; D004041:Dietary Fats / Q000378:metabolism*; D005215:Fasting / Q000378:metabolism*; D005260:Female; D018565:Food-Drug Interactions / Q000502:physiology*; D006801:Humans; D008297:Male; D008875:Middle Aged
chemical_list: D000662:Amphetamines; D003692:Delayed-Action Preparations; D004041:Dietary Fats; C449521:SLI381; D000661:Amphetamine