Abstract

COMPARATIVE BIOAVAILABILITY AND BIOEQUIVALENCE STUDY BETWEEN TABLETS OF OLMESARTAN 40MG+AMLODIPINE 10MG+ HYDROCHLOROTHIAZIDE 25MG: AN OPEN LABEL, BALANCED, RANDOMIZED-SEQUENCE, SINGLE-DOSE, TWO-PERIOD CROSSOVER STUDY IN HEALTHY HUMAN MALE VOLUNTEERS

Kotra Saisudha*

ABSTRACT

Bioavailability and bioequivalence studies play a major role in the development phase for both new drug products and their generic equivalents, and thus attract considerable attention globally. Bioequivalence is a strategy to introduce generic equivalents of brand-name drugs (innovator drugs) to lower the cost of medication through proper assessment as directed by the international regulatory authorities. Concern about lowering health care costs has resulted in a tremendous increase in the use of generic drug products. Thus, Bioavailability and Bioequivalence of drug products and drug product selection have emerged as critical issues in pharmacy and medicine during the last three decades. This present bioequivalence study was designed to determine the bioavailability and bioequivalence of Olmesartan 40mg+ Amlodipine 10mg+ Hydrochlorothiazide 25mg tablets in comparison with Tribenzor® tablets after single dose administration under fasting conditions in healthy adult human male subjects. Therefore the design of an open label, balanced, randomized, single dose, two-treatment, two-sequence, two-period crossover study with a washout period of at least 15days was used.

Keywords: Bioavailability, Bioequivalence, Olmesartan, Amlodipine, Tribenzor, Hydrochlorothiazide.