Pharmacokinetics of Repeated Oral Dosages of CS-866 (Olmesartan medoxomil), Angiotensin II Receptor Antagonist, Planned to be Used Clinically
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Accession number;03A0794395
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| Title;Pharmacokinetics of Repeated Oral Dosages of CS-866 (Olmesartan medoxomil), Angiotensin II Receptor Antagonist, Planned to be Used Clinically |
| Author;
TANAKA TAKANORI
(Aiseikai Osakikurinikku)
URAE RYUJI
(Aiseikai Osakikurinikku)
HISAOKA MASAFUMI
(Sankyo Co., Ltd., JPN)
SHIGA HIROSHI
(Sankyo Co., Ltd., JPN)
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Journal Title;Journal of Clinical Therapeutics & Medicines
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Journal Code:Y0906A
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ISSN:0910-8211
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VOL.19;NO.10;PAGE.1143-1156(2003)
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| Figure&Table&Reference;FIG.5, TBL.12, REF.7 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;CS-866 (Olmesartan medoxomil) is an oral active angiotensin II receptor antagonist and an antihypertensive agent. It is converted to an active metabolite, RNH-6270, after oral administration. The pharmacokinetics, safety and tolerability after multiple administrations of CS-866 at estimated clinical dosages were investigated in this randomizes and single-blinded trial. 10mg, 20mg or 40mg of CS-866 or placebo was orally administrated to 30 healthy male volunteers once daily for 7 consecutive days. Steady state was achieved by Day 5 at a dose of 40mg and by Day 2 at other doses. The accumulation rate (AUC (0-24,Day7)/ AUC (0-.INF.,Day1) of RNH-6270 was 1.06-1.13. AUC and Cmax of RNH-6270 showed linearity with dosage on both Day 1 and Day 7. Renal clearance showed almost same values in this dosage range and didn't change after multiple administrations. Mild dizziness and mild decrease in blood pressure was observed in one subject and considered as a result of the pharmacological action of CS-866. This study suggested the pharmacokinetics of CS-866 is linear and achieves steady state by Day 5 with negligible accumulation rates after multiple administrations, and CS-866 is well tolerated and safe over the dose range investigated. (author abst.) |
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