Justify Sample Size Hike in FDC Trial of Zibotentan-Dapagliflozin, CDSCO Panel Tells AstraZeneca
Written By : Dr. Divya Colin
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2025-05-31 12:34 GMT | Update On 2025-05-31 12:34 GMT
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New Delhi: Reviewing the amendment protocol of the AstraZeneca's fixed dose combination (FDC) Zibotentan plus Dapagliflozin, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) opined that the firm should submit more detailed justification for Increase the number of sample size from 1500 to1800 for further review.
This came after the firm presented protocol amendment version 2.0 dated 14 Feb 2025 protocol no. D4325C00010.
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