Flow Chart of Clinical Phase
The clinical study (Phase-I) on healthy human volunteers was started on as per the approved protocol in presence of the study team (Doctor, Nurse, Phlebotomist, Study Coordinator etc) at Clinical Pharmacology Unit (CPU) of TAAB Biostudy Services. Blood samples per volunteer have been drawn from the subjects during 24 hrs. The concentration of drug in human plasma has to be estimated by the previously developed and validated method by LC MS/MS with a view to evaluate the pK parameters (Cmax, TMax, AUC0-t etc). The Phase-II was conducted accordingly.