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Bioequivalence Study of Palbociclib Tablets in Healthy Volunteers
Yiting Hu1, Na Zhao1, Haojing Song1
1Department of Pharmacy, Hebei General Hospital, Hebei Key Laboratory of Clinical Pharmacy, Shijiazhuang, People's Republic of China.
Drug Design, Development and Therapy
|August 27, 2025
Summary
Palbociclib tablets demonstrated bioequivalence in healthy volunteers under both fasting and fed conditions. This study confirms the interchangeability of the test and reference formulations, ensuring consistent therapeutic outcomes.
Area of Science:
- Pharmacokinetics and Drug Bioequivalence
- Clinical Pharmacology
- Pharmaceutical Sciences
Background:
- Palbociclib is a crucial targeted therapy for certain breast cancers.
- Establishing bioequivalence is essential for generic drug approval and therapeutic interchangeability.
- Understanding the impact of food on drug absorption is vital for optimizing dosing regimens.
Purpose of the Study:
- To assess the bioequivalence of a palbociclib test formulation compared to a reference formulation.
- To evaluate the effect of food intake (fed vs. fasting) on the pharmacokinetic profile of palbociclib.
- To ensure the safety and efficacy of palbociclib formulations.
Main Methods:
- A randomized, open-label, two-treatment, two-sequence crossover bioequivalence study was conducted in 68 healthy volunteers.
- Palbociclib plasma concentrations were determined using high-performance liquid chromatography-mass spectrometry (HPLC-MS).
- Pharmacokinetic parameters, including Cmax, AUC0-t, and AUC0-∞, were analyzed using non-compartmental analysis (NCA) and bioequivalence (BE) statistical methods.
Main Results:
- Geometric mean ratios (T/R) for Cmax, AUC0-t, and AUC0-∞ were within the accepted bioequivalence range (80-125%) under both fasting and fed conditions.
- Specifically, under fasting conditions, ratios were 97.96%, 96.16%, and 96.02%, respectively.
- Under fed conditions, ratios were 95.47%, 96.49%, and 96.36%, respectively, with no significant difference in adverse events between groups.
Conclusions:
- The test and reference formulations of palbociclib tablets are bioequivalent under both fasting and fed conditions.
- The study confirms that food intake does not significantly alter the bioequivalence of palbociclib.
- Both palbociclib formulations exhibited a good safety profile, with similar adverse event rates observed in both groups.
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