Document Detail


Single- and multiple-dose pharmacokinetics of an oral mixed amphetamine salts extended-release formulation in adults.
MedLine Citation:
PMID:  16344836     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVES: Assess the bioavailability of mixed amphetamine salts extended-release (MAS XR) 30-mg capsules and the dose proportionality of pharmacokinetic measures for MAS XR 20, 40, and 60 mg. METHODS: Study A, an open-label single-period study, and Study B, a randomized, open-label, three-way crossover study, were conducted in healthy adults in a clinical research unit. In Study A, 20 subjects received a single MAS XR 30-mg capsule by mouth daily for 7 days. In Study B, 12 subjects received single oral doses of MAS XR 20, 40, and 60 mg separated by 7-14-day washout periods. FINDINGS: Plasma dextroamphetamine (d-amphetamine) and levoamphetamine (l-amphetamine) concentrations were measured using a validated LC-MS/MS method. In Study A, a 3:1 ratio of d-amphetamine to l-amphetamine was observed for AUC0-inf and Cmax. Tmax was 4.2 and 4.3 hours for d-amphetamine to l-amphetamine, respectively. In Study B, for d- and l-amphetamine, statistically significant differences were observed for AUC0-t, AUC0-inf, and Cmax between all doses; there was a linear relationship between pharmacokinetic variables and dose and Tmax was similar for each isomer (range: 4.5-5.3 hours) with all given MAS XR doses. CONCLUSION: The extent of exposure as assessed by mean AUC0-24 and Cmax reflected the 3:1 ratio of d-amphetamine to l-amphetamine in MAS XR 30-mg capsules. The pharmacokinetic profiles of MAS XR 20, 40, and 60 mg are dose proportional for the isomers.
Authors:
Susan B Clausen; Stephanie C Read; Simon J Tulloch
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Publication Detail:
Type:  Comparative Study; Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  CNS spectrums     Volume:  10     ISSN:  1092-8529     ISO Abbreviation:  CNS Spectr     Publication Date:  2005 Dec 
Date Detail:
Created Date:  2005-12-13     Completed Date:  2006-03-08     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  9702877     Medline TA:  CNS Spectr     Country:  United States    
Other Details:
Languages:  eng     Pagination:  6-15     Citation Subset:  IM    
Affiliation:
Shire Pharmaceutical Inc., Wayne, PA 19087, USA.
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MeSH Terms
Descriptor/Qualifier:
Administration, Oral
Adult
Amphetamines / administration & dosage,  adverse effects,  pharmacokinetics*
Attention Deficit Disorder with Hyperactivity / blood*,  drug therapy
Biological Availability
Cross-Over Studies
Delayed-Action Preparations
Dextroamphetamine / blood
Dose-Response Relationship, Drug
Drug Administration Schedule
Female
Humans
Male
Metabolic Clearance Rate
Middle Aged
Stereoisomerism
Chemical
Reg. No./Substance:
0/Amphetamines; 0/Delayed-Action Preparations; 51-64-9/Dextroamphetamine

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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