A Single Dose, Randomized, Open-Label, Cross-Over Bioequivalence Study of Budesonide Pressurized Metered-Dose Inhaler...

Area of Science:

• Pharmacology
• Clinical Pharmacy
• Drug Development

Background:

• Budesonide is a key inhaled glucocorticoid (ICS) for managing asthma in adults and children.
• Ensuring bioequivalence between different formulations is crucial for consistent therapeutic outcomes.

Purpose of the Study:

• To compare the pharmacokinetics and assess bioequivalence of two budesonide pressurized metered-dose inhalers (pMDIs) in healthy Chinese subjects.
• To evaluate the safety and tolerability of the budesonide pMDIs.

Main Methods:

• A randomized, open-label, four-period crossover study involving 32 healthy Chinese subjects.
• Plasma budesonide concentrations were measured using LC-MS/MS up to 16 hours post-dose.
• Bioequivalence was assessed using reference-scaled average bioequivalence (RSABE) and average bioequivalence (ABE) methods.

Main Results:

• The two budesonide pMDIs demonstrated bioequivalence based on pharmacokinetic parameters (Cmax, AUC0-t, AUC0-∞).
• Geometric mean ratios and confidence intervals fell within regulatory acceptance criteria for bioequivalence.
• All reported adverse events were mild to moderate and transient, with no serious adverse events observed.

Conclusions:

• The two 200 μg budesonide pMDIs are bioequivalent and well-tolerated in the studied population.
• This finding supports the interchangeability of these budesonide pMDIs for asthma management.
• The study provides robust data on the pharmacokinetic and safety profiles of budesonide pMDIs in Chinese subjects.