Dr. Reddy gets CDSCO Panel Nod for comparative bioavailability study of Rabeprazole Modified Release capsule
New Delhi: Granting approval to Dr. Reddy's Laboratories for conducting the comparative bioavailability study of the proton pump inhibitor Rabeprazole sodium Modified Release capsule 40mg, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has suggested that the result of the comparative bioavailability study should be presented before the committee for further decision on the grant of permission for the conduct of Phase III clinical trial. .
This came after the firm presented the proposal for the grant of permission for manufacturing and marketing of Rabeprazole Sodium modified release Capsules 40 mg for the treatment of patients with gastro-esophageal reflux disease (GERD) refractory to standard proton pump inhibitor (PPI) therapy along with Phase III clinical trial protocol and comparative bioavailability study protocol before the committee.
Rabeprazole is a proton pump inhibitor (PPI) and as such covalently binds with and inactivates the gastric parietal cell proton pump (H+/K+-ATPase). This inhibits in turn gastric acid production and raises gastric pH.
Rabeprazole is used to treat the symptoms of gastroesophageal reflux disease (GERD), a condition in which the backward flow of acid from the stomach causes heartburn and possible injury of the esophagus (the tube that connects the throat and stomach) in adults and children 12 years of age and older.
At the recent SEC meeting for Gastroenterology and Hepatology held on 23rd May 2023, the expert panel reviewed the proposal presented by Dr. Reddy's Laboratories for grant of permission for the manufacturing and marketing of Rabeprazole Sodium modified release Capsules 40 mg for the treatment of patients with gastroesophageal reflux disease (GERD) refractory to standard PPI therapy along with Phase III clinical trial protocol and the comparative bioavailability study protocol.
After detailed deliberation, the committee recommended for grant of permission to conduct the comparative bioavailability study as per the protocol presented by the firm.
Furthermore, the committee also recommended that the result of the comparative bioavailability study should be presented before the committee for further decision on the grant of permission for the conduct of Phase III clinical trial.
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