Pharmacokinetics, pharmacodynamics, and tolerance of single- and multiple-dose fexofenadine hydrochloride in healthy male volunteers

Clinical Pharmacology and Therapeutics

Volumn 64, Issue 6, 1998, Pages 612-621

  Russell, Tanya ^a   Stoltz, Maxine ^a   Weir, Scott ^a  

^a SANOFI   (France)

Author keywords

[No Author keywords available]

Indexed keywords

FEXOFENADINE; PLACEBO;

ADULT; ALLERGIC RHINITIS; AREA UNDER THE CURVE; ARTICLE; CLINICAL TRIAL; CONCENTRATION RESPONSE; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG ABSORPTION; DRUG EFFECT; DRUG ELIMINATION; DRUG SAFETY; DRUG TOLERANCE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; HUMAN EXPERIMENT; KIDNEY CLEARANCE; MALE; NORMAL HUMAN; ORAL DRUG ADMINISTRATION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL;

ADMINISTRATION, ORAL; ADULT; AREA UNDER CURVE; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; ELECTROCARDIOGRAPHY; HEART CONDUCTION SYSTEM; HISTAMINE ANTAGONISTS; HUMANS; MALE; MIDDLE AGED; REFERENCE VALUES; REGRESSION ANALYSIS; TERFENADINE;

EID: 0032422157     PISSN: 00099236     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0009-9236(98)90052-2     Document Type: Article

References (14)

1. Bernstein DI, Schoenwetter WF, Nathan RA, Storms W, Ahlbrandt R, Mason J. Efficacy and safety of fexofenadine hydrochloride for treatment of seasonal allergic rhinitis. Ann Allergy Asthma Immunol 1997;79:443-8.
2. Tinkelman D, Falliers C, Bronsky E, Kaiser H, Mason J. Efficacy and safety of fexofenadine HCl in fall seasonal allergic rhinitis [abstract]. J Allergy Clin Immunol 1996; 97(1 pt 3):435.
3. Salata JJ, Jurkiewicz NK, Wallace AA, Stupienski III RF, Guinosso Jr PJ, Lynch Jr JJ. Cardiac electrophysiological actions of the histamine Hi-receptor antagonists astemizole and terfenadine compared with chlorpheniramine and pyrilamine. Circ Res 1995;76:110-9.
4. Smith SJ. Cardiovascular toxicity of antihistamines. Otolaryngol Head Neck Surg 1994;111(3 pt 3):348-54.
5. Woosley RL. Cardiac actions of antihistamines. Annu Rev Pharmacol Toxicol 1996;36:233-52.
6. 1Receptor antagonists: comparative tolerability and safety. Drug Saf 1994;10:350-80.
7. Coutant JE, Westmark PA, Nardella PA, Walter SM, Okerholm RA. Determination of terfenadine and terfenadine acid metabolite in plasma using solid-phase extraction and high-performance liquid chromatography with fluorescence detection. J Chromatogr 1991;570:139-48.
8. Pratt C, Mason J, Russell T, Ahlbrandt R. Effect of fexofenadinc HCl on corrected QT interval (QTc). Am J Cardiol [in press].
9. Lippert C, Ling J, Brown P, Burmaster S, Eller M, Cheng L, et al. Mass balance and pharmacokinetics of MDL 16,455A in healthy male volunteers [abstract]. Pharm Res 1995;12(suppl 9):8253.
10. 1blockade effect of fexofenadine. Ann Allergy Asthma Immunol 1997;79:530-2.
11. Day JH, Brisco MP, Welsh A, Mason J. Onset of action, efficacy and safety of a single dose of 60 mg and 120 mg fexofenadine HCl for ragweed (RW) allergy using controlled antigen exposure in an environmental exposure unit (EEU) [abstract]. J Allergy Clin Immunol 1996;97(1 pt 3):2007.
12. Simons FER, Bergman JN, Watson WTA, Simons KJ. The clinical pharmacology of fexofenadine in children. J Allergy Clin Immunol 1996;98(6 pt 1):1062-4.
13. Woosley RL, Chen Y, Freiman JP, Gillis RA. Mechanism of the cardiotoxic actions of terfenadine. JAMA 1993;269:1532-6.
14. Hey JA, del Prado M, Sherwood J, Kreutner W, Egan RW. Comparative analysis of the cardiotoxicity proclivities of second generation antihistamines in an experimental model predictive of adverse clinical ECG effects. Arzneirmittelforschung 1996;46:153-8.