An Open-label, Randomized, Single Oral Dose, Two-period, Two-sequence, Two-way, Crossover Bioequivalence Study on Healthy Adult Male Participants Under Fed Conditions to Compare, Test Product Palbociclib-EVAPHARMA 125 mg Hard Gelatin Capsule, Versus the Reference Product Ibrance™125 mg Capsules (Palbociclib)

Inclusion Criteria:

• Healthy Single Male Participant (18-55 Years Old): Must agree to delay any planned marriage for at least three months after the last dose.

• Body Mass Index (BMI) between 18.5 and 30 kg/m², and body weight of at least 45 kg.

• Participants must have vital signs within the normal range, as defined below, measured at pre-dose:

  • Blood Pressure: Systolic 100-130 mmHg, Diastolic 70-90 mmHg.

  • Pulse Rate: 60-100 beats per minute (bpm).

  • Body Temperature: 36.1-37.2 ºC. Note: Corrective treatment may be provided at the discretion of the Principal Investigator (PI) or Co-Investigator for participants with blood pressure below 90/60 mmHg. If the participant does not respond to treatment, they will be excluded from the study.

    • Participants with normal ECG per the medical opinion of the PI/delegated person
    • No significant medical or surgical history of illness within the last 4 weeks prior to the start of the study, as determined by the Investigator.
    • A normal physical examination at the screening visit without specific abnormalities.
    • Participants with clinically acceptable laboratory investigations mentioned in the Table below:

Note: Results of laboratory investigations within laboratory reference ranges (ALP and creatinine are accepted if below the reference range after being evaluated by the physician as clinically not significant).

Note: Results of Hematologic tests are accepted if within 5% of reference limits after being evaluated by the physician as clinically not significant.

Note: All laboratory tests performed must be evaluated by the investigator; as a normal or medically insignificant. Otherwise, if the result is abnormal medically significant then the result could be confirmed by a new sample. Once the result is confirmed to be abnormal, medically significant, the subject must be excluded Essential Laboratory Tests* Biochemistry Random Blood Sugar, Serum Urea, Serum Creatinine, Alanine Amino Transferase (ALT/GPT), Aspartate Amino Transferase (AST/GOT), Total Bilirubin (serum), Alkaline Phosphatase (serum), Lipid Profile Hematology White blood count, Red blood cell count, Hemoglobin, Hematocrit, MCV, MCH, MCHC, Platelets.

Urinalysis: Specific Gravity, pH, Protein, Glucose, Ketones, Nitrite, Red cells, Pus cells.

Serology: HIV, Hepatitis B, Hepatitis C. Other : ABO blood group & RH. *Evaluation of laboratory tests for the Participants are performed according to the medical decision of the PI/delegated person in accordance to the internal procedure.

•Participants must have laboratory investigation results within clinically acceptable limits as determined by the Principal Investigator (PI) or a delegated medical professional.

Note: The following laboratory tests are considered additional safety parameters, and abnormal results may be accepted if evaluated and assessed as clinically not significant by the PI or delegated person:

Additional Laboratory Tests* Biochemistry : Serum electrolytes (Sodium "Na+", Calcium "Ca++", Potassium "K", Chloride "Cl", Magnesium "Mg", Phosphate), Serum Uric Acid, Serum Lipase and Serum Ferritin Other : Parathyroid hormone (PTH), Immunoglobulin blood test (IgM, IgG and IgA), C-reactive protein (CRP), Antinuclear Antibody (ANA).

Exclusion Criteria:

• Contraindications or Hypersensitivity to Palbociclib, or any of the formulation excipients or related group of drugs.
• History or presence of any medical condition or disease according to the opinion of the principal Investigator.
• History or presence of significant alcoholism or drug abuse in the past one year.
• History or presence of heavy smoking (≥10 cigarettes or consumption of tobacco products and refusal to restrain from smoking or consumption of tobacco products for 48.00 hours before dosing until checkout of the study).
• History or presence of significant renal, hepatobiliary, or liver impairment; a medical or familial history of seizures; significant asthma, urticaria, or other allergic reactions; or any other significant medical condition as determined by the Principal Investigator or their delegate.
• History of difficulty with donating blood or difficulty in accessibility of veins
• Difficulty in swallowing Capsules
• Use of any prescribed medication or OTC medicines or herbal medicines during the last two weeks preceding the first dosing.
• Participants who have any food allergy, intolerance, restriction or special diet during the four weeks before screening.
• Participation in a drug research study within past 2 months from the planned day of first dose administration.
• Donation of blood in the past 2 months before screening.
• Refusal to abstain from water for at least one hour prior to study drug administration and for at least one-hour post dose.
• Refusal to abstain from food for at least ten hours before dosing.
• Refusal to abstain from alcohol or methylxanthine-containing beverages or foods (coffee, tea, carbonated drinks, chocolate) from 2 days prior to dosing till last sample collection.
• Participants with a positive test for HBs-Ag, HIV-Ab, or HCV-Ab
• Subject with positive drug abuse test in urine at the time of check-in.
• Evidence of an uncooperative attitude.