Influence of Food Intake on Pharmacokinetics of CS-866 (Olmesartan Medoxomil), an Angiotensin II Receptor Antagonist

Accession number;03A0865485
Title;Influence of Food Intake on Pharmacokinetics of CS-866 (Olmesartan Medoxomil), an Angiotensin II Receptor Antagonist
Author; TANAKA TAKANORI (Aiseikai Osakikurinikku) URAE RYUJI (Aiseikai Osakikurinikku) HISAOKA MASAFUMI (Sankyo Co., Ltd., JPN) SHIGA HIROSHI (Sankyo Co., Ltd., JPN)
Journal Title;Journal of Clinical Therapeutics & Medicines
Journal Code:Y0906A
ISSN:0910-8211
VOL.19;NO.11;PAGE.1283-1295(2003)
Figure&Table&Reference;FIG.3, TBL.9, REF.8
Pub. Country;Japan
Language;Japanese
Abstract;CS-866 (Olmesartan medoxomil) is an orally active angiotensin II receptor antagonist and an antihypertensive agent. It is converted to an active metabolite, RNH-6270, after oral administration. The influence of food intake on pharmacokinetics of CS-866 at a single oral dosage was investigated in this trial. Twenty mg of CS-866 was orally administrated to 10 healthy male volunteers under fasting condition or 30 minutes after high-fat or low-fat meal in a three-way crossover manner. AUC0-24 and Cmax of RNH-6270 were compared among the three conditions and 95 % confidence intervals of all the ratios (fed with low-fat meal vs. fasted, fed with high-fat meal vs. fasted and fed with high-fat meal vs. fed with low-fat meal) were within the range from 0.8 to 1.25. 95 % confidence intervals of the difference in tmax of all pairs were below 1 hour. Therefore, pharmacokinetics of CS-866 was considered not to be affected by food intake. Concerning safety, no clinically significant abnormalities were confirmed after any type of food intake. (author abst.)