Pharmacokinetics and pharmacodynamics of multiple-dose terbinafine

Journal of Clinical Pharmacology

Volumn 36, Issue 5, 1996, Pages 452-461

  Nedelman, Jerry R ^a   Gibiansky, Ekaterina ^a   Robbins, Bruce A ^a   Cramer, Jeffrey A ^a   Riefler, John F ^a   Lin, Thomas ^a   Meligeni, John A ^a  

^a Sandoz Pharma Ltd   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

GAMMA GLUTAMYLTRANSFERASE; TERBINAFINE;

ADULT; AGE; AREA UNDER THE CURVE; ARTICLE; CLINICAL TRIAL; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG EXPOSURE; DRUG HALF LIFE; DRUG SAFETY; FEMALE; GASTROINTESTINAL SYMPTOM; HUMAN; HYPERTENSION; LIVER TOXICITY; MAJOR CLINICAL STUDY; MALE; NEUROTOXICITY; ONYCHOMYCOSIS; ORAL DRUG ADMINISTRATION; POPULATION RESEARCH; PREDICTION; SKIN TOXICITY; SMOKING;

EID: 0029886727     PISSN: 00912700     EISSN: None     Source Type: Journal    
DOI: 10.1002/j.1552-4604.1996.tb05032.x     Document Type: Article

References (22)

1. Berney D, Schuh K: Heterocyclic spiro-naphthalenones. I Synthesis and reactions of some Spiro [(1H-naphthalenone)]-1,3-piperidines. Helv Chim Acta 1978;61:1262-1273.
2. Haneke E, Tausch I, Brautigam M, Weidinger G, Welzel D: Short-duration treatment of fingernail dermatophytosis: a randomized double-blind study with terbinafine and griseofulvin. J Am Acad Dermatol 1995;32:72-77.
3. Stütz A: Synthesis and structure-activity correlations within allylamine antimycotics. Ann N Y Acad Sci 1988;544:46-62.
4. Ryder N. Biochemical mode of action of the allylamine antimycotic agents naftifine and SF 86-327. In, Iwata K, Vanden Bossche H (eds.): In Vitro and In Vivo Evaluation of Antifungal Agents. Amsterdam: Elsevier, 1986:89-99.
5. Faergemann J, Zehender H, Jones T, Maibach I: Terbinafine levels in serum, stratum corneum, dermis-epidermis (without stratum corneum), hair, sebum, and eccrine sweat. Acta Derm Venereol 1990;7:322-326.
6. Faergemann J, Zehender H, Denouel J, Millerioux L: Levels of terbinafine in plasma, stratum corneum, dermis-epidermis (without stratum corneum), sebum, hair and nails during and after 250 mg with terbinafine orally once per day for four weeks. Acta Derm Venereol 1993;73:305-309.
7. Faergemann J, Zehender H, Millerioux L: Levels of terbinafine in plasma, stratum corneum, dermis-epidermis (without stratum corneum), sebum, hair and nails during and after 250 mg terbinafine orally once daily for 7 and 14 days. Clin Exp Dermatol 1994; 19:121-126.
8. Zehender H, Cabiac MD, Denouel J, Faergemann J, Donatsch P, Kutz K, Humbert H: Elimination kinetics of terbinafine from human plasma and tissues following multiple-dose administration, and comparison with 3 main metabolites. Drug Invest 1994;8:203-210.
9. Denouel J, Keller HP, Schaub P, Delaborde C, Humbert H: Determination of terbinafine and its desmethyl metabolite in human plasma by high-performance liquid chromatography. J Chromatogr B 1995;663:353-359.
10. Nedelman JR, Cramer JA, Robbins B, Gibiansky E, Chang CT, Gareffa S, et al: The effect of food on the pharmacokinetics of multiple dose terbinafine in young and elderly healthy subjects. Biopharm Drug Dispos (in press).
11. Nedelman JR, Karara AH, Chang CT, Gibiansky E, McDonald S, Robinson WT: Inferring systemic exposure from a pharmacokinetic screen: model-free and model-based approaches. Stat Med 1995;14:955-968.
12. SAS Institute: SAS/IML Software: Usage and Reference, Version 6. First edition. Cary, NC: SAS Institute, 1989.
13. Jensen JC: Clinical pharmacokinetics of terbinafine (Lamisil). Clin Exp Dermatol 1989;14:110-113.
14. Jensen JC: Pharmacokinetics of Lamisil in humans. J Dermatol Treat 1990;2(suppl):15-18.
15. Kovarik JM, Kirkesseli S, Humbert H, Grass P, Kutz K: Dose proportional pharmacokinetics of terbinafine and its N-demethylated metabolite in healthy volunteers. Br J Dermatol 1992; 126(suppl 39):8-13.
16. Bates DM, Watts DG: Nonlinear Regression Analysis and Its Applications. New York: Wiley, 1988.
17. Boeckmann AJ, Sheiner LB, Beal SL: NONMEM Users Guide, Part V: Introductory Guide. San Francisco, CA: NONMEM Project Group, University of California at San Francisco, 1992.
18. SAS Institute: SAS/STAT User's Guide, Version 6. Fourth edition, Volume 1. Cary, NC: SAS Institute, 1989.
19. Mayersohn M: Special pharmacokinetic considerations in the elderly. In, Evans WE, Schentag JJ, Jusko WD, Relling MV (eds.): Applied Pharmacokinetics: Principles of Therapeutic Drug Monitoring. Third edition. Vancouver: Applied Therapeutics. 1992;9-1-9-43.
20. McGuffey E: Smoking and drug metabolism. Am Pharm 1993;NS 33:20.
21. Finlay AY: Global overview of Lamisil. Br J Dermatol 1994;130(suppl 43):1-3.
22. Gupta AK, Sauder DN, Shear NH: Antifungal agents: an overview. J Am Acad Dermotol 1994;30:911-933.