Pharmacokinetics of once-daily venlafaxine extended release in healthy volunteers

Current Therapeutic Research - Clinical and Experimental

Volumn 58, Issue 8, 1997, Pages 504-514

  Troy, Steven M ^a   Dilea, Clifford ^a   Martin, Patrick T ^a   Leister, Cathie A ^a   Fruncillo, Richard J ^b   Chiang, Soong T ^a  

^a WYETH AYERST RESEARCH   (United States)

^b GRADUATE HOSPITAL   (United States)

Author keywords

Extended release; Pharmacokinetics; Venlafaxine; Volunteers

Indexed keywords

VENLAFAXINE;

ADULT; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG BLOOD LEVEL; DRUG DISPOSITION; FEMALE; FOOD DRUG INTERACTION; HUMAN; HUMAN EXPERIMENT; MALE; MICROENCAPSULATION; NORMAL HUMAN; ORAL DRUG ADMINISTRATION; PHARMACOKINETICS; PRIORITY JOURNAL; STEADY STATE; SUSTAINED RELEASE PREPARATION;

EID: 0030884995     PISSN: 0011393X     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0011-393X(97)80042-2     Document Type: Article

References (27)

1. Holliday SM, Benfield P. Venlafaxine. A review of its pharmacology and therapeutic potential in depression. Drugs. 1995;49:280-294.
2. Haskins JT, Moyer JA, Muth EA, Sigg EB. Inhibition of noradrenergic neuronal activity by the novel bicyclic compounds, WY-45,030 and WY-45,881. Soc Neurosci Abstracts. 1984;10:262. Abstract.
3. Muth EA, Moyer JA, Haskins JT, et al. Biochemical, neurophysiological, and behavioral effects of WY-45,233, its enantiomers, and other identified metabolites of the antidepressant venlafaxine. Drug Dev Res. 1991;23:191-199.
4. Cusack B, Nelson A, Richelson E. Binding of antidepressants to human brain receptors: Focus on newer generation compounds. Psychopharmacology. 1994;114:559-565.
5. Muth EA, Haskins JT, Moyer JA, et al. Antidepressant biochemical profile of the novel bicyclic compound WY-45,030, an ether cyclohexanol derivative. Biochem Pharmacol. 1986;35:4493-4497.
6. Cunningham LA, Borison RL, Carman JS, et al. A comparison of venlafaxine, trazodone, and placebo in major depression. J Clin Psychopharmacol. 1994;14:99-106.
7. Dierick M, Ravizza L, Realini R, Martin A. A double-blind comparison of venlafaxine and fluoxetine for treatment of major depression in outpatients. Prog Neuro-Psychopharmacol Biol Psychiatry. 1996;20:57-71.
8. Guelfi JD, White C, Hackett D, et al. Effectiveness of venlafaxine in patients hospitalized for major depression and melancholia. J Clin Psychiatry. 1995;56:450-458.
9. Schweizer E, Feighner J, Mandos L, Rickels K. Comparison of venlafaxine and imipramine in the acute treatment of major depression in outpatients. J Clin Psychiatry. 1994;55:104-108.
10. Shrivastava R, Cohn C, Crowder J, et al. Long-term safety and clinical acceptability of venlafaxine and imipramine in outpatients with major depression. J Clin Psychopharmacol. 1994;14:322-329.
11. Fahre LF, Putman HP. An ascending single-dose tolerance study of WY-45,030, a bicyclic antidepressant, in healthy men. Curr Ther Res. 1987;42:901-909.
12. Sisenwine SF, Politowski J, Birk K, et al. A prefactory investigation of the metabolic disposition of WY-45,030 in man. Acta Pharmacol Toxicol. 1986;59:312. Abstract.
13. Otton SV, Ball SE, Cheung SW, et al. Venlafaxine oxidation in vitro is catalysed by CYP2D6. Br J Clin Pharmacol. 1996;41:149-156.
14. Howell SR, Husbands GEM, Scatina JA, Sisenwine SF. Metabolic disposition of 14Cvenlafaxine in mouse, rat, dog, rhesus monkey and man. Xenobiotica. 1993;23:349-359.
15. Klamerus KJ, Maloney K, Rudolph RL, et al. Introduction of a composite parameter to the pharmacokinetics of venlafaxine and its active O-desmethyl metabolite. J Clin Pharmacol. 1992;32:716-724.
16. Fisher LE, Ludwig EA, Wald JA, et al. Pharmacokinetics and pharmacodynamics of methylprednisolone when administered at 8 AM versus 4 PM. Clin Pharmacol Ther. 1992;51:677-688.
17. Regazzi MB, Rondanelli R, Vida E, et al. A theophylline dosage regimen which reduces round-the-clock variation in plasma concentrations resulting from diurnal pharmacokinetic variation. Eur J Clin Pharmacol. 1987;33:243-247.
18. Hendeles L, Weinberger M, Milavetz G, et al. Food-induced "dose-dumping" from a oncea-day theophylline product as a cause of theophylline toxicity. Chest. 1985;87:758-765.
19. Toothaker RD, Welling PG. The effect of food on drug bioavailability. Annu Rev Pharmacol Toxicol. 1980;20:173-199.
20. Hicks DR, Wolaniuk D, Russell A, et al. A high-performance liquid Chromatographic method for the simultaneous determination of venlafaxine and O-desmethylvenlafaxine in biological fluids. Ther Drug Monit. 1994;16:100-107.
21. Jusko WJ. Guidelines for collection and analysis of pharmacokinetic data. In: Evans WE, Schentag JJ, Jusko WJ, eds. Applied Pharmacokinetics-Principles of Therapeutic Drug Monitoring. 3rd ed. Vancouver: Applied Therapeutics; 1992:9-54.
22. Food and Drug Administration Office of Generic Drugs. Guidance on statistical procedure for bioequivalence studies using a standard two-treatment crossover design. Rockville, Md: US Food and Drug Administration; July 1992.
23. Schuirman 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.
24. Troy SM, Parker VD, Fruncillo RJ, Chiang ST. The pharmacokinetics of venlafaxine when given in a twice-daily regimen. J Clin Pharmacol. 1995;35:404-409.
25. Welling PG, Lyons LL, Craig WA, Trochta GA. Influence of diet and fluid on bioavailability of theophylline. Clin Pharmacol Ther. 1975;17:475-480.
26. Karin A, Burns T, Wearley L, et al. Food-induced changes in theophylline absorption from controlled-release formulations. Part I. Substantial increased and decreased absorption with Uniphyl tablets and Theo-Dur Sprinkle. Clin Pharmacol Ther. 1985;38:77-83.
27. Pedersen S, Moller-Pedersen J. Erratic absorption of a slow-release theophylline sprinkle product. Pediatrics. 1984;74:534-538.