CDRI LUCKNOW INDIA
The Central Drug Research Institute (CDRI), the public sector premier institution for drug discovery, will soon start Phase 1 clinical trials of a candidate …
Joseph Alexander, New Delhi
Monday, April 14, 2014, 08:00 Hrs [IST]
The Central Drug Research Institute (CDRI), the public sector premier institution for drug discovery, will soon start Phase 1 clinical trials of a candidate drug against malaria and another one to fight diabetes.
The institute has developed and licensed the anti-hyperglycemic candidate drug (CDR134F194) to TVC Sky Shop Ltd., Mumbai. The process of formulation of the drug in a GMP certified company is in progress. The single dose and multi-dose Phase- I clinical trial will be initiated soon at KEM Hospital & Seth GS Medical College in Mumbai. The permission for the trials was already given by the Drugs Controller General of India (DCGI), sources said.
Another candidate drug developed by the CDRI and waiting for the trials is in the therapeutic area of malaria. The single dose pharmacokinetic study in healthy volunteers as per revised protocol approved by DCGI was completed at PGIMER, Chandigarh for the CDRI compound 97/78 (Anti-malarial agent). A total of 16 volunteers completed the trial. The blood samples were analysed inthe Pharmacokinetics & Metabolism division and the final report on single dose pharmacokinetic study submitted to IPCA, Mumbai.