September 5, 2025Clinical Pharmacology in Drug Development

Comparative Bioequivalence Study of 2 Clevidipine Formulations in Healthy Chinese participants: A Single‐Dose, 2‐Period Crossover Trial

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Authors

ZCZhuo ChenChina Pharmaceutical University FLFengshan Li QYQin YuGuangxi Medical University

Discussion

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Implication

Randomized trial evaluated the bioequivalence and safety of a generic clevidipine formulation, indicating comparable results to the reference product.

Key Points

The generic clevidipine formulation met all bioequivalence criteria for pharmacokinetic parameters and safety.
Key metrics like Cmax and AUC0-t were fully contained within the 80%-125% equivalence range, demonstrating effectiveness.
Adverse events were mild and treatment-related in only three participants, indicating a strong safety profile.
The trial involved 32 healthy Chinese adults, highlighting significant findings in this population context.

Cite This Study

Chen et al. (2025) studied this question.

synapsesocial.com/papers/68c238d2b210217d64779dca https://doi.org/10.1002/cpdd.1591

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Implication

Randomized trial evaluated the bioequivalence and safety of a generic clevidipine formulation, indicating comparable results to the reference product.