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Palbociclib Capsule: A Bioequivalence Study in Healthy Subjects Under Fed Conditions to Compare Two Formulations
Marcelo Gomes Davanço1, Thaís Pereira Vespasiano1, Jessé Moisan2
1Medical & Clinical Affairs Department, United Medical Ltda. (a Knight Therapeutics Company), Sao Paulo 04085-001, SP, Brazil.
Pharmaceutics
|February 27, 2026
Summary
This study demonstrated bioequivalence between a generic palbociclib capsule and the reference product in healthy volunteers. Both palbociclib formulations were well-tolerated, supporting regulatory approval for the branded generic product.
Area of Science:
- Pharmacokinetics and Drug Metabolism
- Clinical Pharmacology
- Pharmaceutical Sciences
Background:
- Breast cancer is a leading global cancer in women, with hormone receptor-positive (HR+) advanced cases often treated with CDK4/6 inhibitors like palbociclib.
- Palbociclib is a crucial treatment for HR+ advanced breast cancer, necessitating accessible generic alternatives.
Purpose of the Study:
- To assess the bioequivalence and tolerability of a new palbociclib capsule formulation.
- To support regulatory submission for a branded generic palbociclib product in Latin American markets.
Main Methods:
- An open-label, randomized, single-dose, two-period crossover study in healthy participants.
- Comparison of a test palbociclib 125 mg capsule (Laboratório LKM S.A.) against the reference Ibrance® 125 mg capsule (Pfizer) under fed conditions.
- Pharmacokinetic analysis of palbociclib plasma concentrations using LC-MS/MS, with parameters calculated via non-compartmental methods.
Main Results:
- Geometric mean ratios (90% CIs) for Cmax and AUC0-72 were 107.07% (101.98-112.42) and 109.77% (106.51-113.13), respectively.
- The study enrolled 52 healthy subjects, with 50 completing the trial.
Conclusions:
- The test palbociclib capsule formulation demonstrated bioequivalence to the reference product, meeting regulatory standards.
- Both palbociclib formulations exhibited good tolerability in healthy study participants.
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