CDSCO Panel Allows Ravenbhel to Conduct BE, Phase III Trial of Dapagliflozin, Sacubitril, Valsartan FDC
Drug Trials at PMCH Get Boost with Formation of Ethical Panel
New Delhi: Ravenbhel Healthcare has got the go-ahead from the Subject Expert Committee (SEC), functional under the Central Drugs Standard Control Organization (CDSCO), to conduct the bioequivalence study and Phase III clinical trial of a fixed-dose combination of Dapagliflozin Propanediol Monohydrate plus Sacubitril and Valsartan as a sodium salt complex film-coated tablet.
This came after the firm presented their proposal along with the bioequivalence (BE) study protocol and Phase III clinical trial protocol for Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 5 mg/5 mg/5 mg + Sacubitril and Valsartan as a sodium salt complex 24 mg and 26 mg/49mg and 51 mg/97mg and 103 mg film-coated tablet before the committee.
Dapagliflozin inhibits the sodium-glucose cotransporter 2 (SGLT2), which is primarily located in the proximal tubule of the nephron. SGLT2 facilitates 90% of glucose reabsorption in the kidneys and so its inhibition allows for glucose to be excreted in the urine.
Sacubitril is a prodrug neprilysin inhibitor used in combination with valsartan to reduce the risk of cardiovascular events in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction.
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