Include more Govt sites in Dapagliflozin, Teneligliptin FDC phase 3 trial: CDSCO panel tells Macleods Pharma
New Delhi: Macleods Pharmaceutical has recently received permission from the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) to conduct the proposed bioequivalence (BE) study and Phase III Clinical Trial (CT) study of the popular antidiabetic Fixed Dose Combination (FDC) drug Dapagliflozin premix (5mg/10mg) plus Teneligliptin Hydrobromidehydrate IP (20mg/20mg) tablets.
However, the approval by the CDSCO expert panel has been granted based on the condition that the firm should include a few more government sites in the Phase III CT study.
This came in the wake of the proposal presented by the pharmaceutical major Macleods Pharma along with the BE protocol and Phase III Clinical Trial Protocol before the committee at the 88th SEC meeting for Endocrinology and Metabolism held on 14.07.2021 and 15.07.2021 at CDSCO.
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