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Effect of Food on the Bioavailability of Amlodipine Besylate/Atorvastatin Calcium Combination Tablet
Author(s) -
Chung Menger,
Calcagni Albert,
Glue Paul,
Bramson Candace
Publication year - 2006
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1177/0091270006291097
Subject(s) - amlodipine , library science , medicine , management , computer science , economics , blood pressure
T aimed at simultaneously reducing blood pressure and lipid levels can substantially reduce the occurrence of cardiovascular events. A tablet containing the antihypertensive amlodipine besylate and the lipid-lowering drug atorvastatin calcium has been developed in 11 different combination dose strengths based on currently approved dosages of amlodipine besylate and atorvastatin calcium. Amlodipine is an oral calcium channel blocker (CCB) indicated for the treatment of hypertension and angina, and atorvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor indicated for the treatment of dyslipidemia. A previous study demonstrated that combining the 2 agents in a single tablet does not affect the bioavailability of either drug under fasting conditions. When amlodipine alone is administered with food, its bioavailability is unaffected. When atorvastatin alone is administered with food, the rate and extent of atorvastatin absorption are reduced by approximately 25% and 9%, respectively. This study investigated the effect of a high-fat meal on the bioavailability of a combination tablet containing amlodipine/atorvastatin 10/80 mg in healthy volunteers. The highest dose strength available was selected because it is more likely to demonstrate any effect of food on absorption than is lower dose strengths.