Modify Phase IV CT protocol: CDSCO Panel Tells Alkem on Amoxicillin, Clavulanate Oral Suspension
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the drug major Alkem Pharmaceutical to modify the Phase IV clinical trial protocol of the fixed-dose combination (FDC) drug Amoxicillin plus Clavulanate Potassium oral suspension in accordance with the Inclusion criteria, dose of the Potassium Clavulanate, sites of study.
This came after the firm presented the Phase IV clinical trial protocol before the committee, in light of the condition mentioned in permission in Form CT-23 dated 10.09.2021.
In line with the inclusion criteria, the expert panel suggested that inclusion criteria should be changed for Community-acquired bacterial pneumonia to include microbiology confirmatory tests.
Furthermore, the committee stated that participants should be enrolled in thousands, and North Indian sites should be included to represent pan-Indian representation.
In addition, the committee noted that the dose of Potassium Clavulanate should be corrected.
After detailed deliberation, the committee recommended the following modification in the Phase IV clinical trial Protocol:1. As it is presented as a phase IV clinical study, participants should be enrolled in thousands.2. Inclusion criteria should be changed for Community-acquired bacterial pneumonia to include microbiology confirmatory tests.3. Dose of the Potassium Clavulanate should be corrected.4. North Indian sites should be included to represent pan-Indian representation.
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