Sun Pharma Dapagliflozin, Glimepiride, Metformin FDC gets CDSCO panel nod for phase 3 trial
New Delhi: Pharmaceutical major, Sun Pharma, has got a go-ahead from the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) to conduct a Phase III clinical trial of an anti-diabetic fixed dose combination drug comprising Dapagliflozin Propanediol Monohydrate, Glimepiride, and Metformin Hydrochloride.
The approval has been granted on the condition that the patients who are already on FDC of Glimepiride 1mg + Metformin 1000mg should be included in the study and, accordingly, a revised protocol should be submitted to CDSCO for approval.
This recommendation came after the drug-maker Sun Pharma presented a proposal for Dapagliflozin Propanediol Monohydrate eq to Dapagliflozin 10mg + Glimepiride IP 1mg/2mg + Metformin Hydrochloride IP (as extended release) 1000mg tablets. The firm also presented the bioequivalence (BE) and clinical trial (CT) protocols before the committee.
Dapagliflozin is a sodium-glucose cotransporter 2 inhibitor that is used to treat type 2 diabetes. In adults, dapagliflozin improves glycemic control by blocking glucose resorption in the proximal tubule of the nephron and causing glycosuria when used in conjunction with diet and exercise. On January 8, 2014, the FDA approved dapagliflozin.
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