Pharmacokinetics of dapoxetine, a new treatment for premature ejaculation: Impact of age and effects of a high-fat meal

Journal of Clinical Pharmacology

Volumn 46, Issue 9, 2006, Pages 1023-1029

  Dresser, Mark J ^a   Kang, Dongwoo ^a   Staehr, Peter ^a   Gidwani, Shalini ^a   Guo, Cindy ^a   Mulhall, John P ^b   Modi, Nishit B ^a  

^a ALZA CORPORATION   (United States)

^b WEILL CORNELL MEDICAL COLLEGE   (United States)

Author keywords

Age; Dapoxetine; Food; Pharmacokinetics; Premature ejaculation

Indexed keywords

DAPOXETINE;

ABDOMINAL PAIN; ADULT; AREA UNDER THE CURVE; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIARRHEA; DIET RESTRICTION; DIZZINESS; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG EFFECT; DRUG SAFETY; FEEDING; FOOD INTAKE; GROUPS BY AGE; HEADACHE; HUMAN; LIPID DIET; MALE; NAUSEA; NORMAL HUMAN; PREMATURE EJACULATION; RANDOMIZED CONTROLLED TRIAL; SINGLE BLIND PROCEDURE; VOMITING;

ADOLESCENT; ADULT; AGED; AGING; BENZYLAMINES; CROSS-OVER STUDIES; DIETARY FATS; EJACULATION; FOOD; HUMANS; MALE; MIDDLE AGED; NAPHTHALENES;

EID: 33747054182     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1177/0091270006291033     Document Type: Article

References (23)

1. Patrick DL, Althof SE, Pryor JL, et al. Premature ejaculation: an observational study of men and their partners. J Sex Med. 2005;2:358-367.
2. Symonds T, Roblin D, Hart K, Althof S. How does premature ejaculation impact a man's life? J Sex Marital Ther. 2003;29:361-370.
3. Mccabe MP. Intimacy and quality of life among sexually dysfunctional men and women. J Sex Marital Ther. 1997;23:276-290.
4. Montague DK, Jarow J, Broderick G, et al. AUA guideline on the pharmacologic management of premature ejaculation. J Urol. 2004;172:290-294.
5. Pryor JL, Althof SE, Steidle C, Miloslavsky M, Kell S. Efficacy and tolerability of dapoxetine in the treatment of premature ejaculation. J Urol. 2005;173(suppl):201. Abstract 740.
6. Hiemke C, Hartter S. Pharmacokinetics of selective serotonin reuptake inhibitors. Pharmacol Ther. 2000;85:11-28.
7. Modi NB, Dresser MJ, Simon M, Lin D, Desai D. Single- and multiple-dose pharmacokinetics of dapoxetine hydrochloride, a novel agent for the treatment of premature ejaculation. J Clin Pharmacol. 2006;46:301-309.
8. Celexa (citalopram hydrobromide) [package insert]. New York, NY: Forest Laboratories Inc; 2005. Available at: http://celexa.com/celexa_pi.aspx. Accessed July 19, 2005.
9. PAXIL (paroxetine hydrochloride) [package insert]. Research Triangle Park, NC: GlaxoSmithKline; 2005. Available at: http://us.gsk.com/products/ assets/us_paxil.pdf. Accessed July 19, 2005.
10. Laumann EO, Paik A, Rosen RC. Sexual dysfunction in the United States: prevalence and predictors. JAMA. 1999;281:537-544.
11. Shabsigh R, Perelman MA. Men with both premature ejaculation (PE) and erectile dysfunction (ED) experience lower quality of life than men with either PE or ED alone. Presented at: The XVII World Congress of Sexology; July 10-15, 2005; Montreal, Canada.
12. Singh BN. Effects of food on clinical pharmacokinetics. Clin Pharmacokinet. 1999;37:213-255.
13. Greb WH, Brett MA, Buscher G, et al. Absorption of paroxetine under various dietary conditions and following antacid intake. Acta Psychiatr Scand Suppl. 1989;350:99-101.
14. Ronfeld RA, Wilner KD, Baris BA. Sertraline. Chronopharmacokinetics and the effect of coadministration with food. Clin Pharmacokinet. 1997;32(suppl 1):50-55.
15. Goodnick PJ. Pharmacokinetics of second generation antidepressants: fluoxetine. Psychopharmacol Bull. 1991;27:503-512.
16. US Food and Drug Administration. Center for Drug Evaluation and Research. Guidance for Industry: Food-Effect Bioavailability and Fed Bioequivalence Studies. December 2002. Available at: http://www.fda.gov/cder/guidance/5194fnl. pdf. Accessed July 19, 2005.
17. Gibaldi M, Perrier G. Pharmacokinetics. New York, NY: Marcel Dekker; 1982.
18. 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;15:657-680.
19. Chow S, Liu J, eds. Design and Analysis of Bioavailability and Bioequivalence Studies. New York, NY: Marcel Dekker; 1992:70-125.
20. Abernethy DR, Azarnoff DL. Pharmacokinetic investigations in elderly patients. Clinical and ethical considerations. Clin Pharmacokinet. 1990;19:89-93.
21. Kinirons MT, Crome P. Clinical pharmacokinetic considerations in the elderly. An update. Clin Pharmacokinet. 1997;33:302-312.
22. PROZAC (fluoxetine hydrochloride) [package insert]. Indianapolis, Ind: Eli Lilly and Company; 2005. Available at: http://pi.lilly.com/us/prozac.pdf. Accessed July 19, 2005.
23. Welling PG. Effects of food on drug absorption. Annu Rev Nutr. 1996;16:383-415.