Document Detail


Relative bioavailability of lisdexamfetamine 70-mg capsules in fasted and fed healthy adult volunteers and in solution: a single-dose, crossover pharmacokinetic study.
MedLine Citation:
PMID:  18285619     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
The relative bioavailability of oral lisdexamfetamine dimesylate, a prodrug of d-amphetamine, and active d-amphetamine was assessed in an open-label, single-dose, 3-treatment, 3-period, randomized, crossover study in 18 healthy adult volunteers. Following a fast of at least 10 hours, subjects were administered an intact capsule of 70 mg lisdexamfetamine, a solution containing the capsule contents, or an intact capsule with a high-fat meal. Standard meals started 4 hours following lisdexamfetamine administration. Blood samples were taken predose (0 hours) and 0.5 to 72 hours postdose, and the concentrations of d-amphetamine and lisdexamfetamine were measured. AUC and C(max) for d-amphetamine were similar when lisdexamfetamine 70 mg was administered to healthy adults in the fed or fasted state. The AUC of intact lisdexamfetamine was similar when the latter was taken without food or in solution, but C(max) was lower when lisdexamfetamine was administered with food. The t(max) of d-amphetamine and intact lisdexamfetamine was similar when taken in solution or in the fasted state but was about 1 hour longer when taken with food. Adverse events were typical for amphetamine products. These findings indicate that food does not have a significant effect on d-amphetamine or lisdexamfetamine bioavailability in healthy adults and that lisdexamfetamine was well tolerated.
Authors:
Suma Krishnan; Yuxin Zhang
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  Journal of clinical pharmacology     Volume:  48     ISSN:  0091-2700     ISO Abbreviation:  J Clin Pharmacol     Publication Date:  2008 Mar 
Date Detail:
Created Date:  2008-02-20     Completed Date:  2008-05-19     Revised Date:  2013-04-16    
Medline Journal Info:
Nlm Unique ID:  0366372     Medline TA:  J Clin Pharmacol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  293-302     Citation Subset:  IM    
Affiliation:
New River Pharmaceuticals Inc., 3 W Shore Rd, Belvedere, CA 94920, USA. sumakrishnan@gmail.com
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MeSH Terms
Descriptor/Qualifier:
Administration, Oral
Adult
Area Under Curve
Biological Availability
Blood Pressure / drug effects
Capsules
Cross-Over Studies
Dextroamphetamine / administration & dosage,  adverse effects,  chemistry,  metabolism,  pharmacokinetics*
Eating / physiology*
Fasting / physiology*
Female
Flushing / chemically induced
Food-Drug Interactions
Half-Life
Headache / chemically induced
Humans
Hyperkinesis / chemically induced
Lysine / chemistry,  metabolism
Male
Metabolic Clearance Rate
Molecular Structure
Tachycardia / chemically induced
Chemical
Reg. No./Substance:
0/Capsules; 51-64-9/Dextroamphetamine; 56-87-1/Lysine; SJT761GEGS/lisdexamfetamine dimesylate

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


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