The CARE Technology Lanka (Pvt) Ltd of The Institute for Combinatorial Advanced Research and Education of KDU (KDU-CARE) entered into a research service agreement with CIC Holdings PLC, on the 11th February 2020, to conduct the Bioequivalence (BE) study of Metformin-Extended Release (XR) manufactured by the CIC.
As a requirement of the National Medicine Quality Authority (NMRA) in Sri Lanka, pharmaceuticals imported from other countries and manufactured in the country, needs to be tested for their bioequivalence. Previously, KDU-CARE carried out and successfully completed two BE studies of the drugs, Amoxicillin and Clarythromycin, for the State Pharmaceutical Manufacturing Corporation (SPMC). Both these being immediate release drugs, the current research agreement with the CIC will be the first BE study that will be conducted for an extended release drug.
The BE study of Metformin (XR), which is a randomized, two-treatment, two-period, two-sequence, single-dose, crossover study on healthy volunteers, as recommended by the FDA will be carried out by a team of scientists, from KDU-CARE and the Faculty of Medicine-KDU, Prof. Rohini Fernandopullei, Dr. Himali Jayasinghearachchi, and Dr. Janaka Munasinghe.
