Bioequivalence Study of Palbociclib 125 mg Capsules of Iclos vs. Ibrance (Palbociclib) Capsules 125 mg

Inclusion Criteria: * Healthy male and/or non-pregnant, non-breast feeding female literate volunteers of 18 to 45 years (both years inclusive) with BMI of 18.50 - 30.00 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 and alcohol breath analysis for both males and females, * Negative pregnancy test for females and do not plan to become pregnant during course of the study and for 03 months after completion of study. * Volunteers who are willing to use acceptable methods of contraception during course of the study and for 03 months after completion of study. * Volunteers who can give voluntary 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 Palbociclib 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/ vaccines (including COVID 19 vaccines) within 14 days which potentially modify kinetics / dynamics of Palbociclib or any other medication judged to be clinically significant by the investigator. * History of consumption of grapefruit and/or its products within 10 days prior to the start of study. * Volunteer who had participated in any other clinical study or who had bled during the last 03 months before check-in. * History of consumption of one or more of the below, 48 hours prior to dosing: Xanthine containing food or drinks such as cola, chocolate, coffee or tea, citrus fruits or items (lime, lemon and orange), alcohol and any other food/beverage known to have interactions as deemed by the investigator * History of difficulties in swallowing tablets/capsules.