A Pilot Bioequivalence Study of Pomalidomide

Inclusion Criteria: Healthy male literate volunteers of 18 to 45 years with BMI of 18.50 - 29.99 Kg/m2 and weight \> 50 Kg. Healthy volunteers as evaluated by medical history, vitals and general clinical examination. Normal or clinically insignificant biochemical, hematological, urine and serology parameters. Normal or clinically insignificant ECG. Negative urine test for drugs of abuse, alcohol breath analysis. Volunteers who are willing to use acceptable methods of contraception. Volunteers who can give written informed consent and communicate effectively. Exclusion Criteria: History of any major surgical procedure in the past 03 months. History of any clinically significant cardiac, gastrointestinal, respiratory, hepatic, renal, endocrine, neurological, metabolic, psychiatric and hematological disorders. History of chronic alcoholism/ chronic smoking/ drug of abuse. Volunteers with known hypersensitivity to Pomalidomide or any of the excipients. History of consumption of tobacco containing products within 48 hours prior to proposed time of dosing Volunteer who are positive for hepatitis B surface antigen, anti-hepatitis C antibody, treponemal antibodies and human immunodeficiency virus (HIV 1\&2) antibodies. Present or past history of intake of drugs or any prescription drug or over the counter (OTC) drugs within 14 days which potentially modify kinetics / dynamics of Pomalidomide or any other medication judged to be clinically significant by the investigator. Hi…