An Open Label, Balanced, Randomized, Two Treatments, Two Sequences, Two Periods, Single Dose, Crossover Bioequivalence Study of Palbociclib 125 mg Capsules (Iclos) and Ibrance (Palbociclib) 125 mg Capsules Pfizer in Healthy Subjects Under Fed Condition

Fecha de inicio: 6 de febrero de 2024

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.