Lack of effect of orlistat on the bioavailability of a single dose of nifedipine extended-release tablets (Procardia XL) in healthy volunteers

Journal of Clinical Pharmacology

Volumn 36, Issue 4, 1996, Pages 352-355

  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

ENZYME INHIBITOR; LIPASE INHIBITOR; NIFEDIPINE; PLACEBO; TETRAHYDROLIPSTATIN; UNCLASSIFIED DRUG;

ADULT; AREA UNDER THE CURVE; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DOUBLE BLIND PROCEDURE; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG FORMULATION; FEMALE; HUMAN; HUMAN EXPERIMENT; MALE; NORMAL HUMAN; ORAL DRUG ADMINISTRATION; RANDOMIZED CONTROLLED TRIAL; SUSTAINED RELEASE PREPARATION;

EID: 0029960012     PISSN: 00912700     EISSN: None     Source Type: Journal    
DOI: 10.1002/j.1552-4604.1996.tb04211.x     Document Type: Article

References (14)

1. Hadvàry P, Lengsfeld H, Wolfer H: Inhibition of pancreatic lipase in vitro by the covalent inhibitor tetrahydrolipstatin. Biochem J 1988;256;357-361.
2. Borgström B: Mode of action of tetrahydrolipstatin: a derivative of the naturally occurring lipase inhibitor lipstatin. Biochim Biophys Acta 1988;962:308-316.
3. Fernandez E, Borgström B: Effects of tetrahydrolipstatin, a lipase inhibitor, on absorption of fat from the intestine of the rat. Biochim Biophys Acta 1989;1001:249-255.
4. 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.
5. Murad F: Drugs used for the treatment of angina: organic nitrates, calcium-channel blockers, and β-adrenergic antagonists. In, Gilman AG, Rall TW, Nies AS, Taylor P (eds.): The Pharmacological Basis of Therapeutics. Eighth edition. New York: Pergamon Press, 1990:764-783.
6. Pfizer Pratt Pharmaceuticals: Procardia XL package insert. In, Physicians' Desk Reference. Forty-ninth edition. Montvale, NJ: Medical Economics Data, 1995:1907-1910.
7. 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.
8. Grizzle JE: The two-period change-over design and its use in clinical trials. Biometrics 1965;21:467-480.
9. Grizzle JE: Corrections to the two-period change-over design and its use in clinical trials. Biometrics 1974;30:727.
10. Bolton S: Pharmaceutical Statistics: Practical and Clinical Applications. New York: Marcel Dekker, 1984.
11. Chung M, Reitberg DP, Gaffney M, Singleton W: Clinical pharmacokinetics of nifedipine gastrointestinal therapeutic system: a controlled-release formulation of nifedipine. Am J Med 1987; 83(suppl 6B):10-14.
12. Crome P, Müller FO, Wijayawardhana P, Groenewoud G, Hundt HKL, Leighton G, et al: Single dose and steady-state pharmacokinetic profiles of nifedipine GITS tablets in healthy elderly and young volunteers. Drug Invest 1993;5:193-199.
13. Romero AJ, Chung M, Messig M, Coates P, Monsen L: Comparative pharmacokinetics and pharmacodynamics of nifedipine GITS and nifedipine INDAS under fed and fasted conditions (abstract). Clin Pharmacol Ther 1994, 55:196.
14. Reitberg D, Chung M, Blickens D, Gaffney M, Singleton W: Effect of food on nifedipine GITS pharmacokinetics (abstract no. D07-W-34). J Pharm Sci 1987;76(suppl):S92.