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BioequivalencePhase 1PalbociclibNCT07922564

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

A Phase 1 study testing Palbociclib-EVAPHARMA 125 mg Hard Gelatin Capsule and Ibrance capsules in people with Bioequivalence and Male, run by Zi Diligence Biocenter at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Bioequivalence study of two Capsules formulation of Palbociclib in healthy male participants Read more about this study

Who is it for?
Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Bioequivalence, Male
What is being tested?
Palbociclib-EVAPHARMA 125 mg Hard Gelatin Capsule and Ibrance capsules
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteEgypt
Study dates
9 Feb 2026to 19 Feb 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.
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  • 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).

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Zi Diligence Biocenter

    Cairo, Cairo Governorate, 19653

Other trials in Egypt

About this study

Bioequivalence study of two Capsules formulation of Palbociclib in healthy male participants

Read the detailed description

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

Conditions
Bioequivalence, Male
Being tested
Palbociclib-EVAPHARMA 125 mg Hard Gelatin Capsule, Ibrance capsules
Keywords
Bioequivalence, Zi-Diligence, Zi Diligence Biocenter

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Palbociclib-EVAPHARMA 125 mg Hard Gelatin CapsuleDrug

    Test Product

  • Ibrance capsulesDrug

    Reference product

Study groups in NCT07922564
Study groupRoleWhat they receive
TRExperimentalsequence of crossover design
Receives: Drug: Palbociclib-EVAPHARMA 125 mg Hard Gelatin Capsule
RTOthersequence of crossover design
Receives: Drug: Ibrance capsules

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cmax

    Determine Bioequivalence for Cmax

    Measured: 72 hours

  2. AUC0-T

    Determine Bioequivalence for AUC0-T

    Measured: 72 hours

Secondary outcomes (3)

  1. Tmax

    Compare Tmax

    Measured: 72 hours

  2. Kel

    Compare kelimination

    Measured: 72 hours

  3. Half life

    Compare elimination half life

    Measured: 72 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2026
  2. Study start9 Feb 2026
  3. Primary completion19 Feb 2026
  4. Study completion19 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Model description
Two-period, Two-sequence, Two-way, Crossover Bioequivalence Study
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07922564
Sponsor's protocol ID
Pal25060
Other IDs
Zi-Pal/Eva-0725-46
Acronym
Palbociclib
Status last verified
Nov 2026
First submitted
2 Nov 2026
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Might be shared if requested

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Palbociclib-EVAPHARMA 125 mg Hard Gelatin Capsule and Ibrance capsules in people with Bioequivalence and Male, run by Zi Diligence Biocenter at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax (time frame: 72 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07922564.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.

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