Dr Reddy's Laboratories gets CDSCO Panel nod to study Rabeprazole Sodium Modified Release Capsules
New Delhi: Dr. Reddy's Laboratories has got the go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to conduct a Phase III clinical trial study of Rabeprazole Sodium Modified Release Capsules 40 mg.
This came after Dr. Reddy’s Laboratories presented a comparative bioavailability study report and Phase III clinical trial protocol before the committee.
Rabeprazole is an antiulcer drug in the class of proton pump inhibitors. It is a prodrug—in the acid environment of the parietal cells it turns into active sulphenamide form. Rabeprazole inhibits the H+, K+ATPase of the coating gastric cells and dose-dependently suppresses basal and stimulated gastric acid secretion.
Rabeprazole is used to treat duodenal ulcers, gastroesophageal reflux disease (GERD), and Zollinger-Ellison syndrome, a condition where the stomach produces too much acid. It may also be used together with antibiotics (eg, amoxicillin, clarithromycin) to treat ulcers associated with infections caused by H. pylori.
At the recent SEC meeting for gastroenterology and hepatology held on February 27, 2025, the expert panel reviewed the comparative bioavailability study report and Phase III clinical trial protocol.
After detailed deliberation, the committee considered the comparative bioavailability study report and recommended the grant of permission to conduct a Phase III clinical trial study as per the protocol presented by the firm.
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