The effect of orlistat on the pharmacokinetics of phenytoin in healthy volunteers

Journal of Clinical Pharmacology

Volumn 36, Issue 7, 1996, Pages 654-658

  Melia, Angela T ^a   Mulligan, Thomas E ^a   Zhi, Jianguo ^a  

^a HOFFMANN LA ROCHE INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

PHENYTOIN; TETRAHYDROLIPSTATIN;

ADULT; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE TIME EFFECT RELATION; DRUG ABSORPTION; DRUG BLOOD LEVEL; FAT INTAKE; HUMAN; HUMAN EXPERIMENT; INTESTINE ABSORPTION; LIPID ABSORPTION; MALE; NORMAL HUMAN; ORAL DRUG ADMINISTRATION; RANDOMIZED CONTROLLED TRIAL; SINGLE BLIND PROCEDURE;

EID: 0029741559     PISSN: 00912700     EISSN: None     Source Type: Journal    
DOI: 10.1002/j.1552-4604.1996.tb04231.x     Document Type: Article

References (19)

1. Parke-Davis: Kapseals Dilantin package insert. In, Physicians' Desk Reference. Forty-ninth edition. Montvale, NJ: Medical Economics Data, 1995; 1832-1833.
2. Tozer TN, Winter ME: Phenytoin. In, Evans WE, Schentag JJ, Jusko WJ (eds.): Applied Pharmacokinetics: Principles of Therapeutic Drug Monitoring. Third edition. Vancouver, WA: Applied Therapeutics, 1992; 25-1-25-44.
3. Melander A, Brante G, Johansson Ö, Lindberg T, Wahlin-Boll E: Influence of food on the absorption of phenytoin in man. Eur J Clin Pharmacol 1979; 15:269-274.
4. Sekikawa H, Nakano M, Takada M, Arita T: Influence of dietary components on the bioavailability of phenytoin. Chem Pharm Bull 1980; 8:2443-2449.
5. Johansson Ö, Wahlin-Boll E, Lindberg T, Melander A: Opposite effects of carbohydrate and protein on phenytoin absorption in man. Drug-Nutr Interact 1983; 2:139-144.
6. Hamaguchi T, Shinkuma D, Irie T, Yamanaka Y, Morita Y, Iwamoto B, et al: Effect of a high-fat meal on the bioavailability of phenytoin in a commercial powder with a large particle size. Int J Clin Pharmacol Ther Toxicol 1993; 31:326-330.
7. Randinitis EJ, Buchanan RA, Kinkel AW: Pharmacokinetic profile of a 300-mg extended phenytoin sodium capsule (Dilantin) formulation. Epilepsia 1990; 31:458-464.
8. Hadvàry P, Lengsfeld H, Wolfer H: Inhibition of pancreatic lipase in vitro by the covalent inhibitor tetrahydrolipstatin. Biochem J 1988; 256; 357-361.
9. Borgström B: Mode of action of tetrahydrolipstatin: a derivative of the naturally occurring lipase inhibitor lipstatin. Biochim Biophys Acta 1988; 962:308-316.
10. Zhi J, Melia AT, Guerciolini R, Chung J, Kinberg J, Hauptman JB, Patel IH: Retrospective population-based analysis of the dose - response (fecal fat excretion) relationship of orlistat in normal and obese volunteers. Clin Pharmacol Ther 1994; 56:82-85.
11. Zhi J, Melia AT, Eggers H, Joly R, Patel IH: Review of limited systemic absorption of orlistat, a lipase inhibitor, in healthy human volunteers. J Clin Pharmacol 1995; 35:1103-1108.
12. Maya MT, Farinha AR, Lucas AM, Morais JA: Sensitive method for the determination of phenytoin in plasma, and phenytoin and 5-(4-hydroxyphenyl)-5-phenylhydantoin in urine by high-performance liquid chromatography. J Pharm Biomed Anal 1992; 10:1001-1006.
13. Grizzle JE: The two-period change-over design and its use in clinical trials. Biometrics 1965; 21:467-480.
14. Grizzle JE: Corrections to the two-period change-over design and its use in clinical trials. Biometrics 1974; 30:727.
15. Middle MV, Müller FO, Schall R, Groenewoud G, Hundt HKL, Huber R, et al: No influence of pantoprazole on the pharmacokinetics of phenytoin. Int J Clin Pharmacol Ther 1995; 33:304-307.
16. Zhi J, Melia AT, Koss-Twardy SG, Min BH, Guerciolini R, Freundlich NL, et al: The influence of orlistat on the pharmacokinetics and pharmacodynamics of glyburide in healthy volunteers. J Clin Pharmacol 1995; 35:521-525.
17. Melia AT, Zhi J, Koss-Twardy SG, Min BH, Smith BL, Freundlich NL, et al: The influence of reduced dietary fat absorption induced by orlistat on the pharmacokinetics of digoxin in healthy volunteers. J Clin Pharmacol 1995; 35:840-843.
18. Melia AT, Mulligan TE, Zhi J: Lack of effect of orlistat on the bioavailability of a single dose of nifedipine extended-release tablets (Procardia XL) in healthy volunteers. J Clin Pharmacol 1996; 36:352-355.
19. Zhi I, Melia AT, Guerciolini R, Koss-Twardy SG, Passe SM, Rakhit A, Sadowski JA: The effect of orlistat on the pharmacokinetics and pharmacodynamics of warfarin in healthy volunteers. J Clin Pharmacol (in press).