A Single-Dose, Two-Way Crossover, Bioequivalence Study of Dexmethylphenidate HCl with and without Food in Healthy Subjects

Journal of Clinical Pharmacology

Volumn 44, Issue 2, 2004, Pages 173-178

  Teo, Steve K ^a   Scheffler, Michael R ^a   Wu, Anfan ^a   Stirling, David I ^a   Thomas, Steve D ^a   Stypinski, Daria ^b   Khetani, Vikram D ^a  

^a CELGENE CORPORATION   (United States)

^b MDS Inc   (Canada)

Author keywords

Attention deficit hyperactivity disorder; Dexmethylphenidate HCl; Food drug interactions

Indexed keywords

DEXMETHYLPHENIDATE; DRUG METABOLITE; RITALINIC ACID;

ADULT; AREA UNDER THE CURVE; ARTICLE; ATTENTION DEFICIT DISORDER; BIOEQUIVALENCE; CHIRALITY; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIET RESTRICTION; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG METABOLISM; FEMALE; FOOD DRUG INTERACTION; FOOD INTAKE; HUMAN; ISOMER; LIPID DIET; MALE; NERVOUSNESS; NORMAL HUMAN; SIDE EFFECT; SOMNOLENCE; STATISTICAL SIGNIFICANCE; STEREOSPECIFICITY; XEROSTOMIA;

ADULT; AREA UNDER CURVE; BIOLOGICAL AVAILABILITY; CENTRAL NERVOUS SYSTEM STIMULANTS; CROSS-OVER STUDIES; FASTING; FEMALE; FOOD-DRUG INTERACTIONS; HALF-LIFE; HUMANS; INTESTINAL ABSORPTION; MALE; METHYLPHENIDATE; POSTPRANDIAL PERIOD; STEREOISOMERISM; THERAPEUTIC EQUIVALENCY;

EID: 1642535376     PISSN: 00912700     EISSN: None     Source Type: Journal    
DOI: 10.1177/0091270003261899     Document Type: Article

References (22)

1. Rowland AS, Umbach DM, Catoe KE, Stallone L, Long S, Rabiner D, et al: Studying the epidemiology of attention-deficit hyperactivity disorder: screening method and pilot results. Can J Psychiat 2001;46:931-940.
2. Barbaresi W, Katusic S, Colligan R, Oankratz V, Weber K, Mrazek D, et al: How common is attention-deficit/hyperactivity disorder? Incidence in a population-based cohort in Rochester, Minnesota. Arch Pediatr Adolesc Med 2002;156:217-224.
3. Cyr M, Brown C: Current drug therapy recommendations for the treatment of attention deficit hyperactivity disorder. Drugs 1998;56:215-223.
4. Sunohara GA, Malone MA, Rovet J, Humphries T, Roberts W, Taylor MJ: Effect of methylphenidate on attention in children with attention deficit hyperactivity disorder (ADHD): ERP evidence. Neuropsychopharm 1999;21:218-228.
5. Elia J, Ambrosini PJ, Rapoport JL: Treatment of attention-deficit hyperactivity disorder. N Engl J Med 1999;340:780-788.
6. Evans SW, Pelham WE: Psychostimulant effects on academic and behavioral measures for ADHD junior high school students in a lecture format classroom. J Abnorm Child Psychol 1991;19:537-552.
7. Kimko HC, Cross JT, Abernethy DR: Pharmacokinetics and clinical effectiveness of methylphenidate. Clin Pharmacokin 1999;37:457-470.
8. Patrick KS, Muller RA, Gualtieri CT, Breese GR: Pharmacokinetics and actions of methylphenidate, in: Meltzer H (ed.), Psychopharmacology: The Third Generation of Progress. New York: Raven, 1987;1387-1395.
9. Szporny L, Gorog P: Investigations into the correlations between monoamine oxidase inhibition and other effects due to methylphenidate and its stereoisomers. Biochem Pharmacol 1961;8:263-268.
10. Patrick KS, Caldwell RW, Ferris RM, Breese GR: Pharmacology of the enantiomers of threo-methylphenidate. J Pharmacol Exp Ther 1987;241:152-158.
11. Srinivas N, Hubbard J, Korchinski E, Midha K: Enantioselective pharmacokinetics of d,l-threo-methylphenidate in humans. Pharm Res 1993;10:14-21.
12. Srinivas N, Hubbard J, Quinn D, Midha K: Enantioselective pharmacokinetics and pharmacodynamics of d,l-threo-methylphenidate in children with attention deficit hyperactivity disorder. Clin Pharmacol Ther 1992;52:561-568.
13. Singh B: Effects of food on clinical pharmacokinetics. Clin Pharmacokinet 1999;37:213-255.
14. Yoss R, Daly D: On the treatment of narcolepsy. Med Clin North Am 1968;52:781-787.
15. Oettinger L: Methylphenidate: a review. South Med J 1976;69:161-163.
16. Gaultieri C, Wargin W, Kanoy R, Youngblood W, Breese G: The effects of eating and fasting on the absorption of methylphenidate. Res Commun Psychol Psychiatry Behav 1982;7:381-384.
17. Chan Y-PM, Swanson J, Soldin S, Thiessen J, Macleod S, Logan W: Methylphenidate hydrochloride given with or before breakfast: II. Effects on plasma concentration of methylphenidate and ritalinic acid. Pediatrics 1983;72:56-59.
18. Modi N, Wang B, Hu W, Gupta S: Effect of food on the pharmacokinetics of osmotic controlled-release methylphenidate in healthy subjects. Biopharm Drug Dispos 2000;21:23-31.
19. Midha K, McKay G, Rawson M, Korchinski E, Hubbard J: Effect of food on the pharmacokinetics of methylphenidate. Pharm Res 2001;18:1185-1189.
20. Srinivas N, Hubbard J, Korchinski E, Midha K: Stereoselective urinary pharmacokinetics of dl-threo-methylphenidate and its major metabolite in humans. J Pharm Sci 1992;81:747-749.
21. Aoyama T, Kotaki H, Honda Y, Nakagawa F: Kinetic analysis of enantiomers of threo-methylphenidate and its metabolite in 2 healthy subjects after oral administration as determined by a gas chromatographic-mass spectrometric method. J Pharm Sci 1990;79:465-469.
22. Gualtieri C, Wargin W, Kanoy R, Patrick K, Shen C, Youngblood W, et al: Clinical studies of methylphenidate serum levels in children and adults. J Am Acad Child Psychiatry 1982;21:19-26.