Synokem gets CDSCO Panel nod to study FDC Torsemide plus Eplerenone film coated tablet
New Delhi: Considering the bioequivalence (BE) report of the fixed-dose combination (FDC) Torsemide IP 10mg/ 20mg plus Eplerenone IP 25mg/25mg film-coated tablet presented by Synokem Pharmaceutical, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved to conduct the Phase III clinical trial (CT) for the proposed drug combination.
This came after Synokem Pharmaceutical presented its proposal along with a request to reconsider the BE study report and revise the Phase III clinical trial protocol before the committee.
Eplerenone plus Torasemide is primarily used to remove excess water from the body. It also maintains the bloodstream's potassium level and prevents hypertension (high blood pressure) due to edema (fluid retention).
Torsemide belongs to the pyridine-sulfonylurea class of loop diuretics. Its primary site of activity is the thick ascending limb of the loop of Henle, where it blocks active reabsorption of sodium and chloride, resulting in diuresis, natriuresis, and other effects.
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