Pharmacokinetics of duloxetine hydrochloride enteric-coated tablets in healthy Chinese volunteers: A randomized, open-label, single- and multiple-dose study

Clinical Therapeutics

Volumn 31, Issue 5, 2009, Pages 1022-1036

  Zhao, Rui ke ^a   Cheng, Gang ^a   Tang, Jing ^a   Song, Juan ^a   Peng, Wen Xing ^a  

^a CENTRAL SOUTH UNIVERSITY   (China)

Author keywords

duloxetine; healthy volunteer; LC MS MS; pharmacokinetics

Indexed keywords

DULOXETINE; FLUOXETINE;

ADULT; AREA UNDER THE CURVE; ARTICLE; CHINESE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DECREASED APPETITE; DIARRHEA; DISTRIBUTION VOLUME; DIZZINESS; DOSAGE SCHEDULE COMPARISON; DRUG ACCUMULATION; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DOSE COMPARISON; DRUG ELIMINATION; DRUG INDUCED HEADACHE; DRUG TOLERABILITY; ENTERIC COATED TABLET; EVENING DOSAGE; FEMALE; HALF LIFE TIME; HUMAN; HUMAN EXPERIMENT; LIQUID CHROMATOGRAPHY; MALE; MASS SPECTROMETRY; MAXIMUM PLASMA CONCENTRATION; MORNING DOSAGE; NAUSEA; NORMAL HUMAN; OPEN STUDY; PLASMA CONCENTRATION-TIME CURVE; RANDOMIZED CONTROLLED TRIAL; REPRODUCIBILITY; SENSITIVITY AND SPECIFICITY; SINGLE DRUG DOSE; TIME TO MAXIMUM PLASMA CONCENTRATION;

ADULT; ANALYSIS OF VARIANCE; ANTIDEPRESSIVE AGENTS; AREA UNDER CURVE; CHINA; CHROMATOGRAPHY, LIQUID; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; HUMANS; MALE; REFERENCE VALUES; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY; TABLETS, ENTERIC-COATED; TANDEM MASS SPECTROMETRY; THIOPHENES; YOUNG ADULT;

EID: 66949149842     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2009.05.005     Document Type: Article

References (18)

1. Tran P.V., Bymaster F.P., McNamara R.K., and Potter W.Z. Dual monoamine modulation for improved treatment of major depressive disorder [published correction appears in J Clin Psychopharmacol. 2003;23:425]. J Clin Psychopharmacol 23 (2003) 78-86
2. Vaishnavi S.N., Nemeroff C.B., Plott S.J., et al. Milnacipran: A comparative analysis of human monoamine uptake and transporter binding affinity. Biol Psychiatry 55 (2004) 320-322
3. Turcotte J.E., Debonnel G., de Montigny C., et al. Assessment of the serotonin and norepinephrine reuptake blocking properties of duloxetine in healthy subjects. Neuropsychopharmacology 24 (2001) 511-521
4. Bech P., Kajdasz D.K., and Porsdal V. Dose-response relationship of duloxetine in placebo-controlled clinical trials in patients with major depressive disorder. Psychopharmacology (Berl) 188 (2006) 273-280
5. Skinner M.H., Kuan H.Y., Skerjanec A., et al. Effect of age on the pharmacokinetics of duloxetine in women. Br J Clin Pharmacol 57 (2004) 54-61
6. Hirschfeld R.M., and Vornik L.A. Recognition and diagnosis of bipolar disorder. J Clin Psychiatry 65 Suppl 15 (2004) 5-9
7. Mallinckrodt C.H., Prakash A., Andorn A.C., et al. Duloxetine for the treatment of major depressive disorder: A closer look at efficacy and safety data across the approved dose range. J Psychiatr Res. 40 (2006) 337-348
8. Lantz R.J., Gillespie T.A., Rash T.J., et al. Metabolism, excretion, and pharmacokinetics of duloxetine in healthy human subjects. DrugMetab Dispos 31 (2003) 1142-1150
9. Stahl S.M., and Grady M.M. Essential Psychopharmacology: The Pre-scriber's Guide (2006), Cambridge University Press, Cambridge, UK; New York, NY 155-160 Rev and updated ed
10. Dunner D.L., Goldstein D.J., Mallinckrodt C., et al. Dulox-etine in treatment of anxiety symptoms associated with depression. Depress Anxiety 18 (2003) 53-61
11. Sweetman S.C. Martindale: The Complete Drug Reference. 34th ed. (2004), Pharmaceutical Press, London, UK 291
12. Ishigooka J., Nagata E., Takahashi A., et al. Simultaneous monitoring of inhibition of serotonin uptake by platelets and plasma drug concentrations following administration of duloxetine, a new antidepressant candidate, to healthy volunteers. Curr Ther Res Clin Exp. 58 (1997) 679-692
13. Ma N., Zhang B.K., Li H.D., et al. Determination of duloxetine in human plasma via LC/MS and subsequent application to a pharmacokinetic study in healthy Chinese volunteers. Clin Chim Acta 380 (2007) 100-105
14. Tianmei S., Knadler M.P., Lim M.T., et al. Pharmacokinetics and tolerability of duloxetine following oral administration to healthy Chinese subjects. Clin Pharmacokinet 46 (2007) 767-775
15. Hua T.C., Pan A., Chan C., et al. Effect of duloxetine on tolterodine pharmacokinetics in healthy volunteers. Br J Clin Pharmacol 57 (2004) 652-656
16. Suri A., Reddy S., Gonzales C., et al. Duloxetine pharma-cokinetics in cirrhotics compared with healthy subjects. Int J Clin Pharmacol Ther. 43 (2005) 78-84
17. Li Y., Jiang X., Lan K., et al. Pharmacokinetic properties of rosuvastatin after single-dose, oral administration in Chinese volunteers: A randomized, open-label, three-way crossover study. Clin Ther. 29 (2007) 2194-2203
18. Arnold L.M., Rosen A., Pritchett Y.L., et al. A randomized, double-blind, placebo-controlled trial of duloxe-tine in the treatment of women with fibromyalgia with or without major depressive disorder. Pain 119 (2005) 5-15