The Institute for Combinatorial Advanced Research and Education of KDU (KDU-CARE), successfully completed the Bioequivalence (BE) study of Clarithromycin for the State Pharmaceutical Manufacturing Corporation (SPMC).
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. Accordingly, the SPMC requested KDU to conduct bioequivalence studies for one of their drugs, Clarithromycin. The project was undertaken by the KDU-CARE, and was led by a team of scientists, from KDU-CARE and the Faculty of Medicine-KDU, Prof. Rohini Fernandopullei, Dr. Himali Jayasinghearachchi, Dr. Darshana De Silva, Dr. Janaka Munasinghe and Dr. Prasad Premaratne. The study is a randomized, two-treatment, two-period, two-sequence, single-dose, crossover, BE study on Clarithromycin in healthy subjects.
The final report of the study was submitted to the Chairman of SPMC, Dr Uthpala Indrawansa and his team, by the Vice Chancellor of KDU, Director-KDU-CARE and the research team, on 1st December 2020. Previously also, KDU-CARE carried out and completed a BE study for Amoxicillin drug for SPMC. This is the second BE study to successfully complete by KDU-CARE.
