Single- and multiple-dose pharmacokinetics of ziprasidone under non-fasting conditions in healthy male volunteers

British Journal of Clinical Pharmacology

Volumn 49, Issue SUPPL. 1, 2000, Pages 5-13

  Miceli, J J ^a   Wilner, K D ^a   Hansen, R A ^a   Johnson, A C ^a   Apseloff, G ^b   Gerber, N ^b  

^a PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United States)

^b OHIO STATE UNIVERSITY   (United States)

Author keywords

Extrapyramidal symptoms; Pharmacokinetics; Serum prolactin; Ziprasidone

Indexed keywords

PROLACTIN; ZIPRASIDONE;

ADULT; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG TOLERABILITY; ELECTROCARDIOGRAM; EXTRAPYRAMIDAL SYNDROME; HEADACHE; HUMAN; HUMAN EXPERIMENT; MALE; NORMAL HUMAN; ORTHOSTATIC HYPOTENSION; PRIORITY JOURNAL; PROLACTIN BLOOD LEVEL; RANDOMIZED CONTROLLED TRIAL; SCHIZOPHRENIA; SEDATION;

EID: 0034018456     PISSN: 03065251     EISSN: None     Source Type: Journal    
DOI: 10.1046/j.1365-2125.2000.00147.x     Document Type: Article

References (28)

1. Seeger TF, Seymour PA, Schmidt AW, et al. Ziprasidone (CP-88,059): a new antipsychotic with combined dopamine and serotonin receptor antagonist activity. J Pharmacol Exp Ther 1995; 275: 101-113.
2. 2 antagonism in schizophrenia: clinical. Extrapyramidal and neuroendocrine response in a preliminary study with risperidone (R 64766). Hum Psychopharmacol 1990; 5: 225-231.
3. Metropolitan height and weight tables. Stat Bull Metrop Life Found 1983; 64: 3-9.
4. Janiszewski JS, Fouda HG, Cole RO. Development and validation of a high-sensitivity assay for an antipsychotic agent, CP-88,059, with solid-phase extraction and narrow-bone, high-performance liquid chromatography. J Chromatogr 1995; 668: 133-139.
5. Simpson GM, Angus JW. A rating scale for extrapyramidal side effects. Acta Psychiatr Scand 1970; 212(Suppl): 11-19.
6. Barnes TRE. A rating scale for drug-induced akathisia. Br J Psychiatr 1989; 154: 672-676.
7. Guy W. Abnormal Involuntary Movement Scale. In ECDEU Assessment Manual for Psychopharmacology, ed Guy W, Rockville, Maryland, USA Department of Health and Human Services Publication (ADM-76-338), 1976.
8. Rubin RT. Prolactin and schizophrenia. In Psychopharmacology: the Third Generation of Progress, ed Meltzer HY, New York: Raven Press, 1984; 803-808.
9. Mesotten F, Suy E, Pietquin M, et al. Therapeutic effect and safety of increasing doses of risperidone (R 64766) in psychotic patients. Psychopharmacology 1989; 99: 445-459.
10. Muller-Spahn F. Risperidone in the treatment of chronic schizophrenic patients: an international double-blind, parallel-group study versus haloperidol. Clin Neuropharmacol 1992; 15 (1A): 825-835.
11. DeCoster R, Bowden C, Byloos M, et al. Endocrine effects of the new antipsychotic risperidone. Presented at the 9th International Congress of Endocrinology, Nice, France, 1992.
12. Claus A, Bollen J, De Cuyper H, et al. Risperidone versus haloperidol in the treatment of chronic schizophrenic inpatients: a multicentre, double-blind, comparative study. Acta Psychiatr Scand 1992; 85: 295-305.
13. Ereshefsky L, Lacombe S. Pharmacological profile of risperidone. Can J Psychiatry 1993; 38: S80-S88.
14. Cardoni AA. Risperidone: review and assessment of its role in the treatment of schizophrenia. Ann Pharmacother 1995; 29: 610-618.
15. Umbricht D, Kane JM. Risperidone: efficacy and safety. Schizophr Bull 1995; 21: 593-606.
16. Lee HS, Kim CH, Song SH, Choi NK, Yoo KJ. Clozapine does not elevate serum prolactin levels in healthy men. Biol Psychiatry 1995; 38: 762-764.
17. Meltzer HY. The mechanism of action of novel antipsychotic drugs. Schizophr Bull 1991; 17: 263-287.
18. Meltzer HY. Treatment of neuroleptic non-responsive schizophrenic patients. Schizophr Bull 1992; 18: 515-542.
19. Muller EE, Locatelli V, Cella S, Penalva A, Novelli A, Cocchi D. Prolactin-lowering and releasing drugs. Drugs 1983; 25: 399-432.
20. De Koning P, de Vries MH. A comparison of the neuro-endocrinological and temperature effects of DU 29894, flesinoxan, sulpiride and haloperidol in normal volunteers. Br J Clin Pharmacol 1995; 39: 7-14.
21. Rojansky N, Wang K, Halbreich U. Reproductive and sexual adverse effects on psychotropic drugs. In Adverse Effects of Psychotropic Drugs, Guildford Press, 1992; 356-375.
22. Schwartz MF, Bauman JE, Masters WH. Hyperprolactinaemia and sexual disorders in men. Biol Psychiatry 1982; 17: 861-876.
23. Fleischhacker WW, Meise U, Gunther V, et al. Compliance with antipsychotic drug treatment: influence of side effects. Acta Psychiatr Scand 1994; 89: 11-15.
24. Buvat J, Lemaire A, Buvat-Herbaut M, et al. Hyperprolactinemia and sexual function in men. Hormone Res 1985; 22: 196-203.
25. Ataya K, Mercado A, Kartiaginer J, et al. Bone density and reproductive hormones in patients with neuroleptic-induced hyperprolactinemia. Fertil Steril 1988; 50: 876-881.
26. Halbreich U, Rojansky N, Palter S, et al. Decreased bone mineral density in medicated psychiatric patients. Psychosomatic Med 1995; 57: 485-491.
27. Pickar D. Prospects for pharmacotherapy of schizophrenia. Lancet 1995; 345: 557-562.
28. Tandon R, Harrigan E, Zorn SH. Ziprasidone: a novel antipsychotic with unique therapeutic potential. J Serotonin Res 1997; 4: 159-177.