{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T23:44:08Z","timestamp":1792799048640,"version":"4.5.0"},"reference-count":23,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2013,3,7]],"date-time":"2013-03-07T00:00:00Z","timestamp":1362614400000},"content-version":"vor","delay-in-days":918,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["The Journal of Clinical Pharma"],"published-print":{"date-parts":[[2010,9]]},"abstract":"<jats:p>The pharmacokinetics of lisdexamfetamine dimesylate, a long\u2010acting prodrug stimulant, and its active moiety, d\u2010amphetamine, including dose\u2010proportionality and variability, were assessed in 20 healthy adults. Subjects received a single dose, sequentially, of 50, 100, 150, 200, and 250 mg of lisdexamfetamine dimesylate. Plasma lisdexamfetamine dimesylate and d\u2010amphetamine were measured before dosing and 0.25 to 96 hours postdose. Dose\u2010proportionality and intersubject and intrasubject variability of pharmacokinetic parameters were examined. Safety assessments included adverse events. All 20 subjects received 50 and 100 mg while 18, 12, and 9 subjects received 150, 200, and 250 mg of lisdexamfetamine dimesylate, respectively. Ten subjects were discontinued during the study for prespecified stopping rules (2 consecutive hourly readings of blood pressure: systolic &gt;160 mm Hg or diastolic &gt;100 mm Hg). Mean maximum observed plasma concentration (C<jats:sub>max<\/jats:sub>) and area under the concentration\u2014time curve from time 0 to infinity (AUC<jats:sub>0\u2010\u221e<\/jats:sub>) increased linearly and dose\u2010dependently for d\u2010amphetamine. Median time to C<jats:sub>max<\/jats:sub> ranged from 4 to 6 hours for d\u2010amphetamine and 1.0 to 1.5 hours for lisdexamfetamine dimesylate. Intersubject and intrasubject variability over doses from 50 to 150 mg was low (&lt;20%) for both C<jats:sub>max<\/jats:sub> and AUC<jats:sub>0\u2010\u221e<\/jats:sub>. Adverse events included nausea, dizziness, headache, psychomotor hyperactivity, and dysuria. These findings indicate that the pharmacokinetic parameters of d\u2010amphetamine were dose\u2010proportional and predictable over a wide range of lisdexamfetamine dimesylate doses.<\/jats:p>","DOI":"10.1177\/0091270009357346","type":"journal-article","created":{"date-parts":[[2010,2,20]],"date-time":"2010-02-20T02:53:32Z","timestamp":1266634412000},"page":"1001-1010","source":"Crossref","is-referenced-by-count":57,"title":["Lisdexamfetamine Dimesylate: Linear Dose\u2010Proportionality, Low Intersubject and Intrasubject Variability, and Safety in an Open\u2010Label Single\u2010Dose Pharmacokinetic Study in Healthy Adult Volunteers"],"prefix":"10.1002","volume":"50","author":[{"given":"James","family":"Ermer","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert","family":"Homolka","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patrick","family":"Martin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mary","family":"Buckwalter","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jaideep","family":"Purkayastha","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Benno","family":"Roesch","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2013,3,7]]},"reference":[{"key":"e_1_2_7_2_2","doi-asserted-by":"publisher","DOI":"10.1097\/01.chi.0000215326.51175.eb"},{"key":"e_1_2_7_3_2","doi-asserted-by":"publisher","DOI":"10.1542\/peds.105.5.1158"},{"key":"e_1_2_7_4_2","doi-asserted-by":"publisher","DOI":"10.1136\/oem.2007.038448"},{"key":"e_1_2_7_5_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(05)66915-2"},{"key":"e_1_2_7_6_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1056-4993(18)30136-6"},{"key":"e_1_2_7_7_2","doi-asserted-by":"publisher","DOI":"10.1542\/peds.107.6.e105"},{"key":"e_1_2_7_8_2","doi-asserted-by":"publisher","DOI":"10.1097\/00004583-200202001-00003"},{"issue":"11","key":"e_1_2_7_9_2","doi-asserted-by":"crossref","first-page":"15","DOI":"10.4088\/JCP.1107e28","article-title":"Effect of stimulant medications for attention\u2010deficit\/hyperactivity disorder on later substance use and the potential for stimulant misuse, abuse, and diversion","volume":"68","author":"Faraone SV","year":"2007","journal-title":"J Clin Psychiatry"},{"key":"e_1_2_7_10_2","doi-asserted-by":"publisher","DOI":"10.2165\/00023210-200822070-00005"},{"key":"e_1_2_7_11_2","doi-asserted-by":"publisher","DOI":"10.1097\/chi.0b013e31815a56f1"},{"key":"e_1_2_7_12_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.clinthera.2008.05.006"},{"key":"e_1_2_7_13_2","unstructured":"PennickM.Hydrolytic conversion of lisdexamfetamine dimesylate to the active moiety d\u2010amphetamine. 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