<p>Comparison of Bioavailability and Bioequivalence of Generic and Brand Name Formulations of Escitalopram Oxalate Tablets in Healthy Chinese Population Under Fasting and Fed Conditions</p>

Abstract

This study compared the bioequivalence of two formulations of escitalopram oxalate 20 mg tablets in terms of bioavailability and tolerability in healthy Chinese male and female subjects. Patients and Methods: A randomized, single-blind, two-period, two-sequence crossover study was performed under fasting and fed conditions, with a 21-day washout period. In total, 24 healthy subjects (18 males and 6 females) were enrolled in the fasting test and the fed test, respectively. Blood samples were collected over 168 h post-dose in each period. The concentrations of escitalopram in plasma were determined by high-performance liquid chromatography coupled with a tandem mass spectrometry. Pharmacokinetic parameters used for bioequivalence assessment were determined from the drug concentration data using noncompartmental analysis. Results: All subjects showed good medication compliance. The 90% confidence intervals (CIs) for the geometric mean ratios of AUC 0-t , AUC 0-∞ , and C max were within the bioequivalence acceptance criteria (80.00% to 125.00%). Adverse events were recorded and no deaths or serious adverse events (SAEs) occurred. Conclusion: Escitalopram oxalate 20 mg tablets produced in China were bioequivalent to the reference formulation (Lexapro ®) in healthy Chinese male and female subjects under fasting and fed conditions.

CYP2C19 Genotyping May Provide a Better Treatment Strategy when Administering Escitalopram in Chinese Population

“…The PK parameters showed no statistical difference between the fed and fasting groups, i.e., food might not alter the PK parameters in Chinese population. The results are similar with the results of previous studies in other races (Søgaard et al, 2005;Li et al, 2020;Landy and Estevez, 2021), indicating that escitalopram can be administered with or without meals in Chinese population. Then, the PK parameters showed no statistical difference between male and female, i.e., gender does not affect the PK parameters in Chinese population.…”

“…Therefore, the guidelines based on the Caucasians may not be applicable to the Chinese, which induced the establishment of a guideline in China. Escitalopram was approved for usage in China for 15 years, and it is the first-line antidepressant medication in China (Li et al, 2020). Therefore, it is necessary to evaluate the effect of CYP2C19 genotypes on the PK parameters on Chinese population to provide a basis for the individualized medication guidance of escitalopram in China.…”

Estudo de bioequivalência entre duas formulações contendo oxalato de escitalopram

“…Validação do método Assim como em outros trabalhos publicados, a técnica analítica selecionada para o estudo para a quantificação de escitalopram nas amostras de plasma humano foi LC-MS/MS [12][13][14][16][17][18][19] .…”

“…Os medicamentos referência e teste apresentaram média de concentração plasmática máxima Cmáx de 24,629ng/mL e 24,525ng/mL, respectivamente, coerentes com aqueles encontrados em literatura 12,14 .…”