Abstract
Bioequivalence study of two Irbesartan/Hydrochlorothiazide tablet formulations in Mexican healthy volunteers
Highlights
Cardiovascular disease accounts for approximately 17 million deaths a year, nearly one third of the total [1]
According to the Mexican regulations, it may be concluded that both formulations are bioequivalent
It followed the Good Clinical Practices Guidelines [15], the ethical principles for medical research for humans stated in the Declaration of Helsinki [16], the General Health Law of Mexico (Ley General de Salud, México) [17], and the Regulations of the General Health Law for Health Research (Reglamento de la ley General de Salud en Materia de Investigación para la Salud, México) [18]
Summary
Cardiovascular disease accounts for approximately 17 million deaths a year, nearly one third of the total [1]. Complications of hypertension account for 9.4 million deaths worldwide every year [2]. Hypertension is responsible for at least 45% of deaths due to heart disease, and 51% of deaths due to stroke [1]. A person over the age of 55 years has a 90% lifetime risk of developing hypertension [3]. Hypertension plays a major etiologic role in the development of cerebrovascular disease, ischemic heart disease, cardiac and renal failure [3]. Treating hypertension has been associated with about 40% reduction in the risk of stroke and about a 15% reduction in the risk of myocardial infarction [5]
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