HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS		QUICK SEARCH:   [advanced] Author: Keyword(s): Year:  Vol:  Page:
Sign In to gain access to subscriptions and/or personal tools.

This Article Full Text Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Request Permissions Request Reprints Citing Articles Citing Articles via Web of Science (2) Citing Articles via Google Scholar Google Scholar Articles by Rohatagi, S. Articles by Salazar, D. E. Search for Related Content PubMed PubMed Citation Articles by Rohatagi, S. Articles by Salazar, D. E. Social Bookmarking                         What's this?

Pharmacokinetics of Amlodipine and Olmesartan After Administration of Amlodipine Besylate and Olmesartan Medoxomil in Separate Dosage Forms and as a Fixed-Dose Combination

From Daiichi Sankyo Inc, Parsippany, New Jersey (Dr Rohatagi, Dr Lee, Dr Haworth, Dr Bathala, Dr Heyrman, Dr Salazar); MDS Pharma Services, Neptune, New Jersey (Dr Shenouda, Dr Noveck); MDS Pharma Services, Phoenix, Arizona (Dr Allison); and MDS Pharma, Quebec, Canada (Dr Rubets).

The pharmacokinetics of amlodipine and olmesartan in healthy volunteers after coadministration of amlodipine besylate and olmesartan medoxomil concomitantly as separate dosage forms and together in a fixed-dose combination tablet were characterized in 5 phase I, randomized, crossover studies. The mean steady-state pharmacokinetics of amlodipine and olmesartan were similar when olmesartan medoxomil 40 mg/day and amlodipine 10 mg/day were administered separately or concomitantly for 10 days. The total and maximum exposure to amlodipine and olmesartan after administration of fixed-dose combination amlodipine/olmesartan medoxomil 10 mg/40 mg was bioequivalent to amlodipine 10 mg plus olmesartan medoxomil 40 mg. The ratio of least squares mean and 90% confidence intervals for the area under the drug concentration-time curve from time zero to time t, from time zero to infinity, and the maximum observed plasma drug concentration of amlodipine and olmesartan fell within the prespecified range for bioequivalence (80.0%-125.0%). The area under the drug concentration-time curve from time zero to time t, from time zero to infinity, and the maximum observed plasma drug concentration of both drugs also met the prespecified criterion for bioequivalence when the fixed-dose combination tablet was taken 30 minutes after a high-fat breakfast. Total exposure to amlodipine and olmesartan was dose-proportional after administration of olmesartan medoxomil 10 mg to 40 mg in the fixed-dose combination formulation with amlodipine 5 mg to 10 mg. From a pharmacokinetic perspective, the 2 drugs are well suited to coadministration in a fixed-dose combination.

Key Words: Pharmacokinetics • amlodipine • olmesartan • bioavailability • bioequivalence

Address for reprints: Shashank Rohatagi, PhD, Daiichi Sankyo Pharma Development, 399 Thornall Street, Edison, NJ 08837; e-mail: srohatagi{at}dsus.com.

CiteULike    Complore    Connotea    Del.icio.us    Digg    Reddit    Technorati    Twitter    What's this?