Bioequivalence study between two formulations of betamethasone dipropionate and betamethasone disodium phosphate injectable suspension in healthy adults

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DOI:

https://doi.org/10.30968/rbfhss.2024.153.1138

Abstract

Objective: To evaluate bioequivalence between two formulations of 5,0 mg/mL betamethasone dipropionate + 2,0 mg/mL betamethasone disodium phosphate injectable suspension in healthy adults under fasting condition. Methods: The study was an open label, randomized, single dose, 2x2 crossover study in 36 healthy adult subjects under fasting conditions. Betamethasone concentrations in human plasma were determined using a validated liquid chromatography coupled to a tandem mass spectrometer detector method. Results: Statistical analysis has determined confidence intervals, power of the test and p-value for sequence effect to the pharmacokinetic parameters Cmax, AUC0-t and AUC0-∞. The geometric mean ratio (90%CI) of the test drug/reference drug for betamethasone were 87.74% to 92.23% for Cmax, 93.95% to 98.91% for AUC0-t and 94.36% to 99.95% for AUC0-∞. Power of the test was 100% for all parameters and p-value for sequence effect were 33.39% for Cmax, 19.98% AUC0-t, and 24.32% for AUC0-∞. Conclusion: Reference and test formulations are statistically bioequivalent and, therefore, interchangeable, according to the local and international criteria, since confidence intervals for Cmax and AUC0-t ratios were within 80% and 125%, according to Anvisa resolution RE nº 1170/2006.

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Published

2024-09-29

How to Cite

1.
SVERDLOFF C, REZENDE VM, AIHARA CK, ENGUEL V, GUIMARÃES CL, SILVEIRA AM, ANTÔNIO MA. Bioequivalence study between two formulations of betamethasone dipropionate and betamethasone disodium phosphate injectable suspension in healthy adults. Rev Bras Farm Hosp Serv Saude [Internet]. 2024Sep.29 [cited 2024Dec.11];15(3):e1138. Available from: https://www.rbfhss.org.br/sbrafh/article/view/1138

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