The Perception and Pharmacokinetics of a 20-mg Dose of Escitalopram Orodispersible Tablets in a Relative Bioavailability Study in Healthy Men

Clinical Therapeutics

Volumn 33, Issue 10, 2011, Pages 1492-1502

  Nilausen, Dorrit Østergaard ^a   Zuiker, R G J A ^b   van Gerven, Joop ^b  

^a H LUNDBECK A S   (Denmark)

^b CENTRE FOR HUMAN DRUG RESEARCH   (Netherlands)

Author keywords

Bioavailability; Escitalopram; Orodispersible; Pharmacokinetics; Taste; Tolerability

Indexed keywords

ESCITALOPRAM;

ADULT; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; BLOOD SAMPLING; CLINICAL LABORATORY; CONTROLLED STUDY; COUGHING; DIARRHEA; DIZZINESS; DRUG BIOAVAILABILITY; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG SOLUBILITY; DRUG TOLERABILITY; ELECTROCARDIOGRAM; FATIGUE; FLATULENCE; HUMAN; MALE; MAXIMUM PLASMA CONCENTRATION; MYALGIA; NAUSEA; NORMAL HUMAN; ORODISPERSIBLE TABLET; PALATABILITY; PHARYNGITIS; PHYSICAL EXAMINATION; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; RHINITIS; SINGLE DRUG DOSE; SOMNOLENCE; TABLET; TABLET FORMULATION; TIME TO MAXIMUM PLASMA CONCENTRATION; URINALYSIS; VITAL SIGN;

ADMINISTRATION, ORAL; ADOLESCENT; ADULT; BIOLOGICAL AVAILABILITY; CITALOPRAM; CROSS-OVER STUDIES; DATA INTERPRETATION, STATISTICAL; DEGLUTITION; HUMANS; MALE; MIDDLE AGED; QUESTIONNAIRES; SEROTONIN UPTAKE INHIBITORS; SOLUBILITY; TABLETS; TASTE; YOUNG ADULT;

EID: 80054932208     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2011.09.012     Document Type: Article

References (21)

1. Fu Y., Yang S., Jeong S.H., et al. Orally fast disintegrating tablets: developments, technologies, taste-masking and clinical studies. Crit Rev Ther Drug Carrier Syst 2004, 21:433-476.
2. Andersen O., Zweidorff O.K., Hjelde T., Rødland E.A. Problems when swallowing tablets. A questionnaire study from general practice [in Norwegian]. Tidsskr Nor Laegeforen 1995, 115:947-949.
3. Wilkinson T., de Picciotto J. Swallowing problems in the normal ageing population. S Afr J Commun Disord 1999, 46:55-64.
4. Eggenberger S.K., Nelms T.P. Artificial hydration and nutrition in advances Alzheimer's disease: facilitating family decision making. J Clin Nurs 2004, 13:661-667.
5. Finestone H.M., Greene-Finestone L.S. Rehabilitation medicines: diagnosis of dysphagia and its nutritional management for stroke patients. CMAJ 2003, 169:1041-1044.
6. Ekberg O., Feinberg M.J. Altered swallowing function in elderly patients without dysphagia: radiologic findings in 56 cases. AJR Am J Roentgenol 1991, 156:1181-1184.
7. Bitter I., Treuer T., Dilbaz N., et al. Patients' preference for olanzapine orodispersible tablet compared with conventional oral tablet in a multinational, randomized, crossover study. World J Biol Psychiatry 2010, 11:894-903.
8. Perkins A.C., Wilson C.G., Frier M., et al. The use of scintigraphy to demonstrate the rapid esophageal transit of the oval film-coated placebo risedronate tablet compared to a round uncoated placebo tablet when administered with minimal volumes of water. Int J Pharm 2001, 222:295-303.
9. Channer K.S., Virjee J.P. The effect of size and shape of tablets on their esophageal transit. J Clin Pharmacol 1986, 26:141-146.
10. van Schaick E.A., Lechat P., Remmerie B.M., et al. Pharmacokinetic comparison of fast-disintegrating and conventional tablet formulations of risperidone in healthy volunteers. Clin Ther 2003, 25:1687-1699.
11. Hirani J.J., Rathod D.A., Vadalia K.R. Orally disintegrating tablets: a review. Trop J Pharm Res 2009, 8:161-172. Accessed 15 April, 2011. http://www.tjpr.org/vol8_no2/2009_8_2_10_Hirani.pdf.
12. European Department for the Quality of Medicines 2001, 1666-1669. European Pharmacopoeia, Strasbourg, Supplement. 3rd ed.
13. Nutt D.J., Feetam C.L. What one hand giveth the other taketh away: some unpredicted effects of enantiomers in psychopharmacology. J Psychopharmacol 2010, 24:1137-1141.
14. World Medical Association (WMA). Declaration of Helsinki: Ethical principles for medical research involving human subjects adopted by the 18th WMA General Assembly, Helsinki, Finland June 1964 and latest revised, Souel, Korea, 2008.
15. ICH Harmonised Tripartite Guideline E6: Guideline for Good Clinical Practice 1996, Accessed April 15, 2011. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002874.pdf.
16. Guidance for Industry. Bioanalytical Method Validation May 2001, US Food and Drug Administration, Accessed April 15, 2011. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070107.pdf.
17. Rowland M., Tozer T. Clinical Pharmacokinetics, Concepts and Applications 1995, Third Edition.
18. Diletti E., Hauschke D., Steinijans V.W. Sample size determination for bioequivalence assessments by means of confidence intervals. Int J Clin Pharmacol Ther Toxicol 1992, 30:S51-S58.
19. Guidance on the investigation of bioequivalence January 2010, CPMP, Accessed April 15, 2011. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/01/WC500070039.pdf.
20. Guidance for Industry. Bioavailability and Bioequivalence Studies for Orally Administered Drug Products-General considerations March 2003, US Food and Drug Administration, Accessed October 4, 2011. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070124.pdf.
21. Sogaard B., Mengel H., Rao N., Larsen F. The pharmacokinetics of escitalopram after oral and intravenous administration of single and multiple doses to healthy subjects. J Clin Pharmacol 2005, 45:1400-1406.