Submit BE study, Phase III trial protocol: CDSCO panel tells Glenmark on Metformin, Glimepiride, Lobeglitazon FDC
New Delhi: Citing the proposed fixed-dose combination (FDC) is not approved internationally, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has opined the drug major Glenmark Pharmaceuticals to submit bioequivalence (BE) study protocol as well as Phase III clinical trial protocol of antidiabetic fixed dose combination drug, Metformin HCl IP (As extended-release form) 500mg/1000mg plus Glimepiride IP 1mg/1mg plus Lobeglitazone sulfate 0.5mg/0.5mg tablets.
This came after the drug major Glenmark Pharmaceuticals presented their proposal along with a request for BE study and Phase III clinical trial study waiver for the proposed fixed-dose combination (FDC) Metformin HCl IP (As extended-release form) 500mg/1000mg plus Glimepiride IP 1mg/1mg plus Lobeglitazone sulfate 0.5mg/0.5mg tablets.
Metformin is a biguanide antihyperglycemic agent and first-line pharmacotherapy used in the management of type II diabetes. Metformin is considered an antihyperglycemic drug because it lowers blood glucose concentrations in type II diabetes without causing hypoglycemia. It is commonly described as an "insulin sensitizer", leading to a decrease in insulin resistance and a clinically significant reduction of plasma fasting insulin levels.
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