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Pharmacokinetics of a Modified-Release Dexamphetamine Sulfate Formulation Following Single and Multiple Dosing in Healthy Adults: Comparative Bioavailability with Immediate-Release Dexamphetamine Sulfate, between Strengths, Assessment of Food and Meal Composition Effects


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Thomas R, Sanders S, Doust J, Beller E, Glasziou P. Prevalence of Attention-Deficit/Hyperactivity Disorder: A Systematic Review and Meta-analysis. Pediatrics. 2015;135(4):e994–1001. Thomas R Sanders S Doust J Beller E Glasziou P. Prevalence of Attention-Deficit/Hyperactivity Disorder: A Systematic Review and Meta-analysis . Pediatrics . 2015 ; 135 ( 4 ): e994 1001 . Search in Google Scholar

American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. Washington, DC. 5th ed. 2013. American Psychiatric Association . Diagnostic and Statistical Manual of Mental Disorders . Washington, DC . 5th ed. 2013 . Search in Google Scholar

National Institute for Health and Care Excellence. Attention deficit hyperactivity disorder: diagnosis and management [NICE guideline NG87]. 2018. https://www.nice.org.uk/guidance/ng87 Accessed 10 June 2022. National Institute for Health and Care Excellence . Attention deficit hyperactivity disorder: diagnosis and management [NICE guideline NG87] . 2018 . https://www.nice.org.uk/guidance/ng87 Accessed 10 June 2022 . Search in Google Scholar

Wolraich ML, Hagan JF, Allan C, Chan E, Davison D, Earls M, et al. Clinical Practice Guideline for the Diagnosis, Evaluation, and Treatment of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents. Pediatrics. 2019;144(4):e20192528. Wolraich ML Hagan JF Allan C Chan E Davison D Earls M , Clinical Practice Guideline for the Diagnosis, Evaluation, and Treatment of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents . Pediatrics . 2019 ; 144 ( 4 ): e20192528 . Search in Google Scholar

CADDRA – Canadian ADHD Resource Alliance: Canadian ADHD Practice Guidelines, 4.1 Edition, Toronto ON; CADDRA, 2020. CADDRA – Canadian ADHD Resource Alliance: Canadian ADHD Practice Guidelines , 4.1 Edition, Toronto ON ; CADDRA , 2020 . Search in Google Scholar

Deutsche Gesellschaft für Kinder- und Jugendpsychiatrie Psychosomatik und Psychotherapie (DGKJP), Deutsche Gesellschaft für Psychiatrie und Psychotherapie Psychosomatik und Nervenheilkunde (DGPPN), & Deutsche Gesellschaft für Sozialpädiatrie und Jugendmedizin (DGPSJ). (Hrsg). (2018). Langfassung der interdisziplinären evidenz- und konsensbasierten (S3) Leitlinie „Aufmerksamkeitsdefizit-/Hyperaktivitätsstörung (ADHS) im Kindes-, Jugend- und Erwachsenenalter“. AWMF-Registernummer 028-045. https://www.awmf.org/uploads/tx_szleitlinien/028-045l_S3_ADHS_2018-06.pdf Accessed 13 June 2022. Deutsche Gesellschaft für Kinder- und Jugendpsychiatrie Psychosomatik und Psychotherapie (DGKJP), Deutsche Gesellschaft für Psychiatrie und Psychotherapie Psychosomatik und Nervenheilkunde (DGPPN), & Deutsche Gesellschaft für Sozialpädiatrie und Jugendmedizin (DGPSJ). (Hrsg) . ( 2018 ). Langfassung der interdisziplinären evidenz- und konsensbasierten (S3) Leitlinie „Aufmerksamkeitsdefizit-/Hyperaktivitätsstörung (ADHS) im Kindes-, Jugend- und Erwachsenenalter“ . AWMF-Registernummer 028-045 . https://www.awmf.org/uploads/tx_szleitlinien/028-045l_S3_ADHS_2018-06.pdf Accessed 13 June 2022 . Search in Google Scholar

Childress AC, Komolova M, Sallee FR. An update on the pharmacokinetic considerations in the treatment of ADHD with long-acting methylphenidate and amphetamine formulations. Expert Opin Drug Metab Toxicol. 2019;15(11):937–74. Childress AC Komolova M Sallee FR. An update on the pharmacokinetic considerations in the treatment of ADHD with long-acting methylphenidate and amphetamine formulations . Expert Opin Drug Metab Toxicol . 2019 ; 15 ( 11 ): 937 74 . Search in Google Scholar

MEDICE Arzneimittel Pütter GmbH & Co KG. Attentin 5/10/20 mg SmPC. 06/2020. MEDICE Arzneimittel Pütter GmbH & Co KG . Attentin 5/10/20 mg SmPC . 06 / 2020 . Search in Google Scholar

Uebel-von Sandersleben H, Dangel O, Fischer R, Ruhmann M, Huss M. Effectiveness and safety of dexamphetamine sulfate (Attentin®) in the routine treatment of children and adolescents with ADHD: results from a 12-month non-interventional study. Scand J Child Adolesc Psychiatr Psychol. 2021;9:73–86. Uebel-von Sandersleben H Dangel O Fischer R Ruhmann M Huss M. Effectiveness and safety of dexamphetamine sulfate (Attentin®) in the routine treatment of children and adolescents with ADHD: results from a 12-month non-interventional study . Scand J Child Adolesc Psychiatr Psychol . 2021 ; 9 : 73 86 . Search in Google Scholar

European Medicines Agency. EMA/CHMP/EWP/280/96 Rev1. Guideline on the pharmacokinetic and clinical evaluation of modified release dosage forms. 2014. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-pharmacokinetic-clinical-evaluation-modified-release-dosage-forms_en.pdf Accessed 13 June 2022 European Medicines Agency . EMA/CHMP/EWP/280/96 Rev1. Guideline on the pharmacokinetic and clinical evaluation of modified release dosage forms . 2014 . https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-pharmacokinetic-clinical-evaluation-modified-release-dosage-forms_en.pdf Accessed 13 June 2022 Search in Google Scholar

European Medicines Agency. CPMP/EWP/QWP/1401/98 Rev.1/Corr** Guideline on the Investigation of Bioequivalence. London. 20 January 2010.https://www.ema.europa.eu/en/documents/scientific-guideline/ guideline-investigation-bioequivalence-rev1_en.pdf Accessed 13 June 2022. European Medicines Agency . CPMP/EWP/QWP/1401/98 Rev.1/Corr** Guideline on the Investigation of Bioequivalence . London . 20 January 2010 . https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-investigation-bioequivalence-rev1_en.pdf Accessed 13 June 2022 . Search in Google Scholar

European Generic Medicines Association. Revised EMA Bioequivalence Guideline. Questions & Answers. London. June 2010. https://www.medicinesforeurope.com/wp-content/uploads/2016/03/EGA_BEQ_QA_WEB_QA_1_32.pdf Accessed 13 June 2022. European Generic Medicines Association . Revised EMA Bioequivalence Guideline. Questions & Answers . London . June 2010 . https://www.medicinesforeurope.com/wp-content/uploads/2016/03/EGA_BEQ_QA_WEB_QA_1_32.pdf Accessed 13 June 2022 . Search in Google Scholar

Schuirmann DJ. Two at a Time? Or All at Once? International Biometric Society, Eastern North American Region, Spring Meeting. Pittsburgh, PA. March 28–31, 2004. Schuirmann DJ. Two at a Time? Or All at Once? International Biometric Society, Eastern North American Region, Spring Meeting . Pittsburgh, PA . March 28–31 , 2004 . Search in Google Scholar

D’Angelo P. Testing for Bioequivalence in Higher–Order Crossover Designs: Two-at-a-Time Principle Versus Pooled ANOVA. 2nd Conference of the Global Bioequivalence Harmonisation Initiative. Rockville, MD. 15–16 September, 2016. D’Angelo P. Testing for Bioequivalence in Higher–Order Crossover Designs: Two-at-a-Time Principle Versus Pooled ANOVA . 2nd Conference of the Global Bioequivalence Harmonisation Initiative . Rockville, MD . 15–16 September , 2016 . Search in Google Scholar

Berger RL, Hsu JC. Bioequivalence Trials, Intersection-Union Tests and Equivalence Confidence Sets. Stat Sci. 1996;11(4):283–302. Berger RL Hsu JC. Bioequivalence Trials, Intersection-Union Tests and Equivalence Confidence Sets . Stat Sci . 1996 ; 11 ( 4 ): 283 302 . Search in Google Scholar

Watanalumlerd P, Christensen JM, Ayres JW. Pharmacokinetic modeling and simulation of gastrointestinal transit effects on plasma concentrations of drugs from mixed immediate-release and enteric-coated pellet formulations. Pharm Dev Technol. 2007;12(2):193–202. Watanalumlerd P Christensen JM Ayres JW. Pharmacokinetic modeling and simulation of gastrointestinal transit effects on plasma concentrations of drugs from mixed immediate-release and enteric-coated pellet formulations . Pharm Dev Technol . 2007 ; 12 ( 2 ): 193 202 . Search in Google Scholar

Markowitz JS, Patrick KS. The Clinical Pharmacokinetics of Amphetamines Utilized in the Treatment of Attention-Deficit/Hyperactivity Disorder. J Child Adolesc Psychopharmacol. 2017;27(8):678–89. Markowitz JS Patrick KS. The Clinical Pharmacokinetics of Amphetamines Utilized in the Treatment of Attention-Deficit/Hyperactivity Disorder . J Child Adolesc Psychopharmacol . 2017 ; 27 ( 8 ): 678 89 . Search in Google Scholar

Koziolek M, Alcaro S, Augustijns P, Basit AW, Grimm M, Hens B, et al. The mechanisms of pharmacokinetic food-drug interactions – A perspective from the UNGAP group. Eur J Pharm Sci. 2019;134:31–59. Koziolek M Alcaro S Augustijns P Basit AW Grimm M Hens B , The mechanisms of pharmacokinetic food-drug interactions – A perspective from the UNGAP group . Eur J Pharm Sci . 2019 ; 134 : 31 59 . Search in Google Scholar

Tulloch SJ, Zhang Y, McLean A, Wolf KN. 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. Pharmacotherapy. 2002;22(11):1405–15. Tulloch SJ Zhang Y McLean A Wolf KN. 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 . Pharmacotherapy . 2002 ; 22 ( 11 ): 1405 15 . Search in Google Scholar

Stark JG, Engelking D, McMahen R, Sikes C. A randomized crossover study to assess the pharmacokinetics of a novel amphetamine extended-release orally disintegrating tablet in healthy adults. Postgrad Med. 2016;128(7):648–55. Stark JG Engelking D McMahen R Sikes C. A randomized crossover study to assess the pharmacokinetics of a novel amphetamine extended-release orally disintegrating tablet in healthy adults . Postgrad Med . 2016 ; 128 ( 7 ): 648 55 . Search in Google Scholar

Krishnan S, Zhang Y. Relative bioavailability of lisdexamfetamine 70-mg capsules in fasted and fed healthy adult volunteers and in solution: a single-dose, crossover pharmacokinetic study. J Clin Pharmacol. 2008;48(3):293–302. Krishnan S Zhang Y. Relative bioavailability of lisdexamfetamine 70-mg capsules in fasted and fed healthy adult volunteers and in solution: a single-dose, crossover pharmacokinetic study . J Clin Pharmacol . 2008 ; 48 ( 3 ): 293 302 . Search in Google Scholar

Wang Y, Yu M, Yan B, Martin P, Robertson B. Effects of Food on the Bioavailability of Amphetamine in Healthy Adults After Administration of SHP465 Mixed Amphetamine Salts Extended-Release Capsules. Drugs R D. 2019;19(2):167–75. Wang Y Yu M Yan B Martin P Robertson B. Effects of Food on the Bioavailability of Amphetamine in Healthy Adults After Administration of SHP465 Mixed Amphetamine Salts Extended-Release Capsules . Drugs R D . 2019 ; 19 ( 2 ): 167 75 . Search in Google Scholar

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