Dr. Reddy’s Laboratories Gets CDSCO Panel Nod to Study FDC Telmisartan Plus Chlortalidone for Export purpose only
New Delhi: The drug major Dr Reddy’s Laboratories has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct a bioavailability and bioequivalence (BA/BE) study of the fixed-dose combination of Telmisartan and Chlortalidone Tablets (80 mg +12.5 mg) for the export purpose only.
This came after Dr. Reddy’s Laboratories presented Protocol No. 035-24, Version No.: 01, Dated: 29 Apr 2024, and 036-24, Version No.: 01, Dated: 29 Apr 2024 for BA/BE study for export purposes only.
Telmisartan is in a class of medications called angiotensin II receptor antagonists. It works by blocking the action of certain natural substances that tighten the blood vessels, allowing the blood to flow more smoothly and the heart to pump more efficiently.
Chlorthalidone inhibits sodium reabsorption at the level of the distal convoluted tubule and thus chloride via inhibition of the Na-Cl symporter. By removing sodium reabsorption at this location, the distal convoluted tubule of the nephron retains a higher sodium content.
At the recent SEC meeting for Cardiovascular held on 11th September 2024, the expert panel reviewed Protocol No. 035-24, Version No.: 01, Dated: 29 Apr 2024, and 036-24, Version No.: 01, Dated: 29 Apr 2024 for BA/BE study for export purposes only.
After detailed deliberation, the committee recommended the grant of permission to conduct the proposed BA/BE study for the export purpose only with the condition that the firm shall revise the protocol with respect to the following changes:
(i) Inclusion of type of study in the protocol title as PILOT,
(ii) Inclusion of Serum Pregnancy test for the female volunteer at the time of Screening and end of the study.
(iii) Inclusion of the other Pharmacokinetics Parameters for Chlorthalidone.
Accordingly, the expert panel suggested that the firm should submit the revised Protocol to the CDSCO for review.
