The influence of gender and food on the pharmacokinetics of sodium oxybate oral solution in healthy subjects

Journal of Clinical Pharmacology

Volumn 43, Issue 1, 2003, Pages 59-65

  Borgen, Lowell A ^a   Okerholm, Richard ^b   Morrison, Dennis ^c   Lai, Allen ^d  

^a JAZZ PHARMACEUTICALS   (United States)

^b Okerholm and Associates Inc   (United States)

^c Bio Kinetic Clinical Applications   (United States)

^d CPKD Solutions   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

OXYBATE SODIUM;

ADULT; AREA UNDER THE CURVE; ARTICLE; CATAPLEXY; CLINICAL TRIAL; COMPARTMENT MODEL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIET RESTRICTION; DOSE RESPONSE; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG ELIMINATION; DRUG EXCRETION; DRUG HALF LIFE; DRUG MECHANISM; DRUG SAFETY; DRUG TRANSFORMATION; FEMALE; FOOD DRUG INTERACTION; FOOD INTAKE; HUMAN; HUMAN EXPERIMENT; LIPID DIET; MALE; NARCOLEPSY; RANDOMIZED CONTROLLED TRIAL; SEX DIFFERENCE; SIDE EFFECT; URINARY EXCRETION;

ADMINISTRATION, ORAL; ADOLESCENT; ADULT; BIOLOGICAL AVAILABILITY; FEMALE; FOOD-DRUG INTERACTIONS; HUMANS; MALE; MIDDLE AGED; SEX FACTORS; SODIUM OXYBATE; SOLUTIONS;

EID: 0037216410     PISSN: 00912700     EISSN: None     Source Type: Journal    
DOI: 10.1177/0091270002239707     Document Type: Article

References (18)

1. Scrima L: An etiology of narcolepsy-cataplexy and a proposed cataplexy neuromechanism. Int J Neurosci 1981;15:69-86.
2. Mitler MM, Aldrich MS, Koob GF, Zarcone VP: Narcolepsy and its treatment with stimulants. Sleep 1994;17:352-371.
3. Broughton R, Mamalek M: Effects of nocturnal gamma-hydroxybutyrate on sleep/waking patterns in narcolepsy-cataplexy. J Canadien Des Sciences Neurologique 1980;7:23-30.
4. Broughton R, Mamelak M: The treatment of narcolepsy-cataplexy with nocturnal gamma-hydroxybutyrate. J Canadien Des Sciences Neurologique 1979;6:1-6.
5. Bedard M-A, Montplaisir J, Godbout R, Lapierre O: Nocturnal gamma-hydroxybutyrate effect on periodic leg movements and sleep organization of narcoleptic patients. Clin Neuropharm 1989;12:29-36.
6. Lammers GJ, Arends J, Declerck AC, Ferrari MD, Schouwink G, Troost J: Gammahydroxybutyrate and narcolepsy: A double-blind placebo-controlled study. Sleep 1993;16:216-220.
7. Mamelak M, Webster P: Treatment of narcolepsy and sleep apnea with gamma-hydroxybutyrate: A clinical and polysomnographic case study. Sleep 1981;4:105-111.
8. Mamelak M, Scharf MB, Woods M: Treatment of narcolepsy with γ-hydroxybutyrate: A review of clinical and sleep laboratory findings. Sleep 1986;9:285-289.
9. Scharf M, Brown D, Woods M, Brown L, Hirschowitz J: The effects and effectiveness of γ-hydroxybutyrate in patients with narcolepsy. J Clin Psychiatry 1985;46:222-225.
10. Scrima L, Hartman PG, Johnson FH, Hiller FC: Efficacy of gamma-hydroxybutrate versus placebo in treating narcolepsy-cataplexy: Double-blind subjective measured. Biol Psychiatry 1989;26:331-343.
11. Scrima L, Hartman PG, Johnson FH, Thomas EE, Hiller FC: The effects of γ-hydroxybutyrate on the sleep of narcolepsy patients: A double blind study. Sleep 1990;13:479-490.
12. Palatini P, Tedeschi L, Frison G, Padrini R, Zordan R, Gallimberti L, et al: Dose-dependent absorption and elimination of gamma-hydroxybutyric acid in healthy volunteers. Eur J Clin Pharmacol 1993;45:353-356.
13. Scharf MB, Lai AA, Branigan B, Stover R, Berkowitz DB: Pharmacokinetics of gammahydroxybutyrate (GHB) in narcoleptic patients. Sleep 1998;21:507-514.
14. Ferrara SD, Zotti S, Tedeschi L, Frison G, Castagna F, Gallimberti L, et al: Pharmacokinetics of γ-hydroxybutyric acid in alcohol dependent patients after single and repeated oral doses. Brit J Clin Pharmacol 1992;34:231-235.
15. Ferrara SD, Tedeschi L, Frison G, Orlando R, Mazzo M, Zordan R, et al: Effect of moderate or severe liver dysfunction on the pharmacokinetics of γ-hydroxybutyric acid. Eur J Clin Pharmacol 1996;50:305-310.
16. Borgen L, Lane E, Lai A: Xyrem® (sodium oxybate): A study of dose proportionality in healthy human subjects [abstract]. J Clin Pharmacol 2000;40:1053.
17. Palatini P, Ferrara SD: Pharmacokinetics of γ-hydroxybutyric acid. Alcologia 1996;8:185-191.
18. The U.S. Xyrem Multicenter Study Group: A randomized, double blind, placebo-controlled multicenter trial comparing the effects of three doses of orally administered sodium oxybate with placebo for the treatment of narcolepsy. Sleep 2002;25:42-49.