Pharmacokinetics of extended-release and immediate-release formulations of galantamine at steady state in healthy volunteers

Current Medical Research and Opinion

Volumn 21, Issue 10, 2005, Pages 1547-1554

  Zhao, Qinying ^a   Janssens, Luc ^b   Verhaeghe, Tom ^b   Brashear, H Robert ^a   Truyen, Luc ^a  

^a JOHNSON AND JOHNSON PHARMACEUTICAL RESEARCH AND DEVELOPMENT   (United States)

^b JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

Author keywords

Acetylcholinesterase inhibitors; Alzheimer's disease; Extended release; Food effect; Galantamine; Pharmacokinetics

Indexed keywords

DOMPERIDONE; GALANTAMINE; PARACETAMOL;

ACNE; ADULT; ANEMIA; ANOREXIA; ANXIETY DISORDER; AREA UNDER THE CURVE; ARTICLE; BACKACHE; BIOEQUIVALENCE; CLINICAL TRIAL; COGNITIVE DEFECT; COMPARATIVE STUDY; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED DRUG RELEASE; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIZZINESS; DOSE RESPONSE; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG CAPSULE; DRUG FORMULATION; DRUG SAFETY; DYSMENORRHEA; ELECTROCARDIOGRAPHY; FATIGUE; FEMALE; FLATULENCE; FOOD INTAKE; HEADACHE; HEMATURIA; HUMAN; IMMEDIATE DRUG RELEASE; LABORATORY TEST; MALE; MUSCLE DISEASE; MUSCLE WEAKNESS; MYALGIA; NAUSEA; NORMAL HUMAN; PHARYNGITIS; PHASE 1 CLINICAL TRIAL; PHYSICAL EXAMINATION; QT PROLONGATION; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL; RHINITIS; SLOW DRUG RELEASE; SOMNOLENCE; STEADY STATE; THROMBOPHLEBITIS; VISUAL IMPAIRMENT; VOMITING;

ADOLESCENT; ADULT; BIOLOGICAL AVAILABILITY; CROSS-OVER STUDIES; DELAYED-ACTION PREPARATIONS; FEMALE; GALANTAMINE; HUMANS; MALE; MIDDLE AGED;

EID: 27144461223     PISSN: 03007995     EISSN: None     Source Type: Journal    
DOI: 10.1185/030079905X61965     Document Type: Article

References (17)

1. Cummings JL, Frank JC, Cherry D, et al. Guidelines for managing Alzheimer's disease: part I. Assessment. Am Fam Physician 2002;65:2263-72
2. Hebert LE, Scherr PA, Bienias JL, et al. Alzheimer disease in the US population: prevalence estimates using the 2000 census. Arch Neurol2003;60:1119-22
3. Galasko D. An integrated approach to the management of Alzheimer's disease: assessing cognition, function, and behaviour. Eur J Neurol 1998;5(Suppl 4):S9-S17
4. Victoroff J, Mack WJ, Nielson KA. Psychiatric complications of dementia: impact on caregivers. Dement Geriatr Cogn Disord 1998;9:50-5
5. Tariot PN, Solomon PR, Morris JC, et al, and the Galantamine USA-10 Study Group. A 5-month, randomized, placebo-controlled trial of galantamine in AD. Neurology 2000;54:2269-76
6. Wilcock GK, Lilienfeld S, Gaens E, on behalf of the Galantamine International-1 Study Group. Efficacy and safety of galantamine in patients with mild to moderate Alzheimer's disease: multicentre randomised controlled trial. BMJ 2000;321:1-7
7. Raskind MA, Peskind ER, Wessel T, Yuan W, and the Galantamine USA-1 Study Group. Galantamine in AD: A 6-month randomized, placebo-controlled trial with a 6-month extension. Neurology 2000;54:2261-8
8. Rockwood K, Mintzer J, Truyen L, et al. Effects of a flexible galantamine dose in Alzheimer's disease: a randomised, controlled trial. J Neurol Neurosurg Psychiatry 2001;71:589-95
9. Yamada H, Sugiyama T, Ashida T, et al. Medication management skill and regimen compliance are deteriorated in the elderly even without obvious dementia. Yakugaku Zasshi 2001;121:187-90
10. Dezii CM, Kawabata H, Tran M. Effects of once-daily and twice-daily dosing on adherence with prescribed glipizide oral therapy for type 2 diabetes. South Med J 2002;95:68-71
11. Claxton AJ, Cramer J, Pierce C. A systematic review of the associations between dose regimens and medication compliance. Clin Ther 2001;23:1296-310
12. Razadyne ER [prescribing information]. Titusville, NJ: Ortho-McNeil Neurologies, Inc., 2005
13. Reminyl Product Monograph. Toronto: Janssen-Ortho Inc., 2005
14. Brodaty H, Corey-Bloom J, Potocnik FC, et al. Galantamine prolonged-release formulation in the treatment of mild to moderate Alzheimer's disease. Dement Geriatr Cogn Disord. 2005;20:120-32
15. Verhaeghe T, Diels L, de Vries R, de Jong J. Development and validation of a liquid chromatographic-tandem mass spectrometric method for the determination of galantamine in human heparinised plasma. J Chromatogr B 2003;789:337-46
16. Liu JP, Chow S-C. Sample size determination for the two one-sided tests procedure in bioequivalence. J Pharmacokinet Biopharm 1992;20:101-4
17. Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm 1987;15:657-80