Synokem Gets CDSCO Panel Nod to Study Antidiabetic FDC Drug Sitagliptin plus Empagliflozin
New Delhi: The drug major Synokem Pharmaceuticals has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the Phase III clinical trial study of the fixed-dose combination of the antidiabetic drug Sitagliptin Phosphate Monohydrate plus Empagliflozin in two strengths.
This came after Synokem Pharmaceuticals presented the proposal before the committee with a request to the present Phase III protocol in two strengths i.e. clinical trial Sitagliptin Phosphate Monohydrate IP 100mg/100mg plus Empagliflozin 25mg/10mg tablets and requested for bioequivalence (BE) study wavier.
Sitagliptin is an oral dipeptidyl peptidase-4 (DPP-4) inhibitor used for the management of type 2 diabetes mellitus. Inhibition of DPP-4 by sitagliptin slows DPP-4-mediated inactivation of incretins like GLP-1 and GIP. Incretins are released throughout the day and upregulated in response to meals as part of glucose homeostasis. Reduced inhibition of incretins increases insulin synthesis and decreases glucagon release in a manner dependent on glucose concentrations.
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