Bioequivalence Study of Azilsartan Medoxomil 80 mg Tablets (Gedeon Richter Plc., Hungary) and Edarbi® 80 mg Tablets (JSC Nizhpharm, Russia)
brief summary
ACEis are among the most widely used classes of antihypertensive drugs. ARBs have a similar antihypertensive efficacy and protective effect as ACEis, albeit with a somewhat different mechanism for RAS inhibition and a smaller randomized clinical trials' database. A difference between ACEis and ARBs is their tolerability profile, with ARBs having a rate of side effects similar to placebo. Most importantly, the clinical evidence supports a relevant protective role of ARBs toward the CV and renal damage development, as well as the occurrence of major adverse CV events, in hypertensive patients. Moreover, a neutral metabolic effect has been reported upon ARBs administration, in contrast to other antihypertensive agents, such as BBs and diuretics. These properties highlight the use of ARBs as an excellent pharmacological strategy to manage hypertension and its dangerous consequences The purpose of this study is to compare pharmacokinetics (PK), safety, and tolerability of the IMPs Azilsartan medoxomil 80 mg tablets and of Edarbi® 80 mg tablets in healthy adult subjects of both sexes under fasting conditions. Dose proportionality in exposure was established for azilsartan in the azilsartan medoxomil dose range of 20 mg to 320 mg after single or multiple dosing. In the present study the highest available strength of Azilsartan medoxomil 80 mg tablets will be investigated. Administration of this dose is expected to provide accurate and reliable determination of azilsartan plasma concentrations. This is a single center, open label, randomized, four-period, two-sequence, fully replicate, cross-over bioequivalence study in healthy adult subjects of both sexes after single dose administration under fasting conditions. A single oral dose of the IMP (Test IMP: Azilsartan Medoxomil 80 mg tablets or Reference IMP: Edarbi® 80 mg tablets )will be administered under fasting conditions in each of the 4 study periods.
official title
A Single Center, Open Label, Randomized, Four-period, Two-sequence, Fully Replicate, Cross-over Bioequivalence Study of Azilsartan Medoxomil 80 mg Tablets and Edarbi® 80 mg Tablets in Healthy Adult Subjects of Both Sexes Under Fasting Conditions