Influence of diet on the single-dose pharmacokinetics of isosorbide 5-mononitrate and sustained-release isosorbide dinitrate.
The influence of diet on the single-dose pharmacokinetics of isosorbide 5-mononitrate (IS-5-MN) and sustained-release isosorbide dinitrate (ISDN) was studied in 8 healthy male volunteers. The subjects received either a low-calorie/low-fat diet (LCFD) or a high-calorie/high-fat diet (HCFD) according to a cross-over schedule and were administered the drug in tablet form after breakfast. The study was conducted first in 8 subjects who received a 20 mg IS-5-MN tablet and then in 6 of these individuals who received a 20 mg sustained-release ISDN tablet. After oral doses of IS-5-MN, the plasma drug levels declined monoexponentially and could be described by a one-compartment open model. There were no significant differences in the pharmacokinetic parameters for IS-5-MN between the LCFD and the HCFD. After administration of sustained-release ISDN, the plasma ISDN levels showed marked variations both between and within individuals. The increase in the mean AUC0-12 values for ISDN with the HCFD was found to exceed 60%, although there was no significant difference between the two diets.
Sata
H
H
Department of Pharmacy, Fukuoka University Hospital, Japan.
Inoue
K
K
Nii
T
T
Kuroda
T
T
D000284:Administration, Oral; D000328:Adult; D001682:Biological Availability; D018592:Cross-Over Studies; D003692:Delayed-Action Preparations; D018752:Diet, Fat-Restricted; D004041:Dietary Fats / Q000008:administration & dosage; D018565:Food-Drug Interactions; D006801:Humans; D007408:Intestinal Absorption; D007548:Isosorbide Dinitrate / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000493:pharmacokinetics; D008297:Male; D008875:Middle Aged; D014665:Vasodilator Agents / Q000008:administration & dosage / Q000493:pharmacokinetics*
D003692:Delayed-Action Preparations; D004041:Dietary Fats; D014665:Vasodilator Agents; D007548:Isosorbide Dinitrate; C030397:isosorbide-5-mononitrate