title: Lack of drug-drug interaction between cerivastatin and nifedipine.
abstract: Cerivastatin is a novel, potent HMG-CoA reductase inhibitor. It is primarily cleared via demethylation and hydroxylation with involvement of cytochrome P450 (CYP) 3A4 and subsequent biliary and renal excretion of the metabolites. Both cerivastatin and the dihydropyridine calcium antagonist nifedipine, which is primarily metabolized by CYP 3A4, are used concomitantly in the prevention and therapy of coronary heart disease. To study the drug-drug interaction potential, the mutual effects of cerivastatin and nifedipine were investigated in a controlled, randomized, non-blind 3-way crossover study in healthy male subjects. Single oral doses of 0.3 mg cerivastatin or of 60 mg nifedipine were administered either alone or concomitantly under fasting conditions. The mean AUC- and Cmax ratios (combination treatment versus monotherapy) including 90% confidence intervals were 1.04 (0.98 - 1.10) and 1.00 (0.93 - 1.07) for cerivastatin, and 0.98 (0.73 - 1.32) and 0.95 (0.80 - 1. 13) for nifedipine, respectively. Our results indicate that no mutual drug-drug interaction between cerivastatin and nifedipine occurs.
authors.affiliation: Institute of Clinical Pharmacology, Bayer AG, Wuppertal/Cologne, Germany.
authors.forename: R
authors.initials: R
authors.lastname: Sachse
authors.forename: E
authors.initials: E
authors.lastname: Brendel
authors.forename: W
authors.initials: W
authors.lastname: Mück
authors.forename: G
authors.initials: G
authors.lastname: Rohde
authors.forename: K
authors.initials: K
authors.lastname: Ochmann
authors.forename: R
authors.initials: R
authors.lastname: Horstmann
authors.forename: J
authors.initials: J
authors.lastname: Kuhlmann
mesh_terms: D000284:Administration, Oral; D000328:Adult; D019540:Area Under Curve; D001682:Biological Availability; D002121:Calcium Channel Blockers / Q000493:pharmacokinetics*; D018592:Cross-Over Studies; D004347:Drug Interactions; D006207:Half-Life; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000493:pharmacokinetics*; D008297:Male; D009543:Nifedipine / Q000493:pharmacokinetics*; D011725:Pyridines / Q000493:pharmacokinetics*
chemical_list: D002121:Calcium Channel Blockers; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D011725:Pyridines; C086276:cerivastatin; D009543:Nifedipine